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To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 6)

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Belantamab mafodotin
Lenalidomide
Dexamethasone
Bortezomib
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Relapsed / Refractory Multiple Myeloma, Dose escalation, Antibody-Drug Conjugate, Dose expansion, belantamab mafodotin, Combination therapy, Belamaf

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Capable of giving signed informed consent.
  • Male or female, 18 years or older (at the time consent is obtained).
  • Have confirmed diagnosis of Multiple Myeloma (MM) as defined by the IMWG.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 for Arm A and 0 to 2 for Arm B.
  • Have undergone stem cell transplant (SCT), or are considered transplant ineligible.
  • Have been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy.
  • Must have at least ONE aspect of measurable disease, defined as one the following: Urine M-protein excretion >=200 milligram (mg)/24 hours, or; Serum M-protein concentration >=0.5 gram (g)/deciliter (dL) (>=5.0 g/Liter), or; Serum free light chain (FLC) assay: involved FLC level >=10 mg/dL (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
  • Participants with a history of autologous SCT, are eligible for study participation provided the following eligibility criteria are met: Autologous SCT was >100 days prior to study enrollment; No active bacterial, viral, or fungal infection(s) present; Participant meets the remainder of the eligibility criteria.
  • All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 4.03, 2010) must be Grade <= 1 at the time of enrollment, except for alopecia. Participants with Grade 2 neuropathy can be enrolled into Len/Dex treatment arm, but not into Bor/Dex treatment arm.
  • Adequate organ system functions as defined by the laboratory assessments.
  • The contraceptions used by female participants be consistent with local regulations, regarding methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 4 months after the last dose of belantamab mafodotin and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

WOCBP Participants Assigned to Arm A:

  • Due to lenalidomide being a thalidomide analogue with risk for embryo-fetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control (one method that is highly effective; beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment. Thereafter, WOCBP participants must use a contraceptive method that is highly effective (with a failure rate of <1% per year) for a further 3 months, and agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period: Two negative pregnancy tests must be obtained prior to initiating lenalidomide therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing lenalidomide therapy.

WOCBP Participants Assigned to Arm B

  • WOCBP assigned to Arm B must have a negative highly sensitive serum pregnancy test within 72 hours of dosing on C1D1 and agree to use effective contraception during the study and for 4 months after the last dose of belantamab mafodotin or 7 months from the last dose of bortezomib, whichever is longer.
  • Male participants using contraception should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Male participants are eligible to participate if they agree to the following:

Arm A: from the time of first dose of study until 6 months after the last dose of belantamab mafodotin 4 weeks after the last dose of lenalidomide, whichever is longer, to allow for clearance of any altered sperm.

Arm B: from the time of first dose of study until 6 months after the last dose of belantamab mafodotin or 4 months from the last dose of bortezomib (whichever is the longer) to allow for clearance of any altered sperm.

  • Male participants must agree to refrain from donating sperm and either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below.
  • Agree to use a male condom even if they have undergone a successful vasectomy and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse. Male participants should also use a condom with pregnant females. If the female partner of the male participant is pregnant at the time of enrollment, or becomes pregnant during the trial, the male participant must agree to remain abstinent (if it is consistent with their preferred and usual lifestyle) or use a male condom.

Exclusion Criteria:

  • Systemic anti-myeloma therapy (including systemic steroids) within <=14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
  • Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
  • Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
  • Prior allogenic stem cell transplant. Note: Participants who have undergone syngeneic transplant will be allowed only if they have no history and no currently active, graft versus host disease (GvHD).
  • Evidence of active mucosal or internal bleeding.
  • Any major surgery within the last four weeks.
  • Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria.
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
  • Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment).
  • Participants with invasive malignancies other than multiple myeloma are excluded, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. Note: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction.
  • Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system; Uncontrolled hypertension.
  • Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
  • Pregnant or lactating female.
  • Active infection requiring treatment.
  • Known Human immunodeficiency virus (HIV) infection.
  • Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at Screening or within 3 months prior to first dose of study treatment).
  • Current corneal disease except for mild punctuate keratopathy.
  • Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at Screening or within 3 months prior to first dose of study treatment.
  • Current corneal disease except for mild punctute keratopathy.
  • Participants Assigned to Treatment A (belantamab mafodotin plus Len/Dex): Participants unable to tolerate antithrombotic prophylaxis must be excluded; Discontinuation of prior treatment with lenalidomide due to intolerable AEs.
  • Participants Assigned to Treatment B (belantamab mafodotin plus Bor/Dex): Unacceptable AEs from previous bortezomib treatment; Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain from previous bortezomib treatment; Intolerance or contraindications to anti-viral prophylaxis.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A: Belantamab mafodotin+lenalidomide +dexamethasone

Arm B: Belantamab mafodotin+bortezomib+dexamethasone

Arm Description

Participants will receive SINGLE full dose of belantamab mafodotin as 2.5 mg/kg and 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 min infusion. SPLIT: belantamab mafodotin will be administered in two equal divided doses, 2.5 mg/kg SPLIT dose of a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle. STRETCH: belantamab mafodotin will be administered as 1.9 mg/kg dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on.) Participants will also receive Lenalidomide 25 mg or 10 mg orally daily, on Days 1-21 of each 28 day cycle with Dexamethasone, 40 mg weekly per oral (PO)/intravenously (IV) on Days 1,8,15, & 22 of each cycle.

Participants will receive SINGLE full dose of belantamab mafodotin as 3.4 mg/kg; 2.5 mg/kg; 1.9 mg/kg on Day 1 of each 21-day cycle. SPLIT: belantamab mafodotin will be administered in two equal divided doses: 3.4 mg/kg SPLIT as 1.7 mg/kg dose on Day 1 & 1.7 mg/kg dose on Day 8; 2.5 mg/kg SPLIT dosing as 1.25 mg/kg dose on Day 1 & 1.25 mg/kg dose on Day 8 of each 21-day cycle. STRETCH: belantamab mafodotin will be administered as single dose of 2.5 mg/kg on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 & so on), 1.9 mg/kg administered on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 and so on). Step Down(S/D) STRETCH=belantamab mafodotin 2.5 mg/kg dose will be administered on Day 1 C1 followed by 1.9 mg/kg starting dose on Day1 of alternate 21-day cycles C3 onwards (C3,C5,C7, & so on). Bortezomib will be administered at 1.3 mg/m^2 SC/IV on Days 1,4,8, & 11 of every 21-day cycle. Dex will be administered at 20 mg PO or IV on Days 1,2,4,5,8,9,11, & 12 of every 21-day cycle.

Outcomes

Primary Outcome Measures

Number of participants with DLTs, Part 1, Treatment A
The number of participants with DLTs will be reported.
Number of participants with DLTs, Part 1, Treatment B
The number of participants with DLTs will be reported.
Number of participants with AEs and serious adverse events (SAEs), Part 1
AEs and SAEs will be collected.
Number of participants with electrocardiogram (ECG) parameters of potential clinical importance (PCI), Part 1
Twelve-lead ECGs, will be performed, with the participant at designated time points, using an ECG machine, after 5 minutes of rest. The number of participants with PCI values, will be reported.
Number of participants with abnormal hematology parameters, Part 1
Blood sample will be collected for the assessment of hematology parameters.
Number of participants with abnormal clinical chemistry parameters, Part 1
Blood sample will be collected for the assessment of hematology parameters.
Number of participants with abnormal urinalysis parameters, Part 1
Urine samples will be collected for the assessment of urinalysis parameters.
Number of participants with vital signs of PCI, Part 1
Number of participants with abnormal vital signs will be assessed.
Number of participants with AEs and SAEs in Part 2
AEs and SAEs will be collected.
Overall Response Rate (ORR) as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for multiple myeloma (MM), Part 2
ORR defined as percentage (%) of participants achieving >=Partial Response (PR) as defined by the IMWG Uniform Response Criteria for MM.

Secondary Outcome Measures

Maximum plasma concentration (Cmax) for belantamab mafodotin, Part 1 and 2, Treatment A
Serial blood samples will be collected for pharmacokinetic (PK) analysis.
Area under the concentration time curve (AUC) for belantamab mafodotin, Part 1 and 2, Treatment A
Serial blood samples will be collected for PK analysis.
Time to maximum plasma concentration (Tmax) for belantamab mafodotin, Part 1 and 2, Treatment A
Serial blood samples will be collected for PK analysis.
Serum half-life (t1/2) for belantamab mafodotin, Part 1 and 2, Treatment A
Serial blood samples will be collected for PK analysis.
Cmax for belantamab mafodotin, Part 1 and 2, Treatment B
Serial blood samples will be collected for PK analysis.
AUC for belantamab mafodotin, Part 1 and 2, Treatment B
Serial blood samples will be collected for PK analysis.
Tmax for belantamab mafodotin, Part 1 and 2, Treatment B
Serial blood samples will be collected for PK analysis.
t1/2 for belantamab mafodotin, Part 1 and 2, Treatment B
Serial blood samples will be collected for PK analysis.
Cmax for Lenalidomide, Part 1 and 2, Treatment A
Serial blood samples will be collected for PK analysis.
AUC for Lenalidomide, Part 1 and 2, Treatment A
Serial blood samples will be collected for PK analysis.
Tmax for Lenalidomide, Part 1 and 2, Treatment A
Serial blood samples will be collected for PK analysis.
t1/2 for Lenalidomide, Part 1 and 2, Treatment A
Serial blood samples will be collected for PK analysis.
Cmax for Bortezomib, Part 1 and 2, Treatment B
Serial blood samples will be collected for PK analysis.
AUC for Bortezomib, Part 1 and 2, Treatment B
Serial blood samples will be collected for PK analysis.
Tmax for Bortezomib, Part 1 and 2, Treatment B
Serial blood samples will be collected for PK analysis.
t1/2 for Bortezomib, Part 1 and 2, Treatment B
Serial blood samples will be collected for PK analysis.
Number of participants with anti-drug antibodies (ADAs) against belantamab mafodotin, Part 1 and 2, Treatment A
The number of participants with ADAs will be assessed.
Number of participants with ADAs, against belantamab mafodotin, Part 1 and 2, treatment B
The number of participants with ADAs will be assessed.
Change from Baseline in symptoms and impacts as measured by Ocular Surface Disease Index (OSDI), Part 1 and 2
The OSDI, is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. The OSDI has demonstrated good reliability, validity, sensitivity, and specificity, and can be used as a complement to other clinical and subjective measures of dry eye disease by providing a quantifiable assessment of dry eye symptom frequency and the impact of these symptoms on vision-related functioning. The OSDI will be measured at every 4-weeks, for Treatment A and every 3-weeks, for Treatment B.
Change from Baseline in symptoms and impacts as measured by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), Part 1 and 2
The NEI-VFQ-25, consists of a base set of 25 vision-targeted questions representing, 11 vision-related constructs, plus an additional single-item, general health rating question. These include, a global vision rating (1 item); difficulty with near vision activities (3 items); difficulty with distance vision activities (3 items); limitations in social functioning due to vision (2 items); role limitations due to vision (2 items); dependency on others due to vision (3 items); mental health symptoms due to vision (4 items); driving difficulties (3 items); limitations with peripheral vision (1 item), limitations with color vision (1 item); and Ocular pain (2 items). Scores will be measured, every 4-weeks, for Treatment and every 3-weeks, for Treatment B.
Change from Baseline in symptoms and impacts as measured by Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE), Part 1 and 2
The PRO-CTCAE is a participant-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 80 symptomatic toxicities drawn from the CTCAE.
Number of participants with AEs and SAEs, Part 2
AEs and SAEs will be collected.
Number of participants with AEs of special interest (AESI), Part 1 and 2
The AEs of special interest will be collected.
Number of participants with ophthalmic findings on ophthalmic exam, Part 1 and 2
The ophthalmic examinations will be done, by an ophthalmologist (or optometrist), to assess participants who develop corneal events, during the study.
Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30), Part 1 and 2
EORTC QLQ-C30, is a 30-item questionnaire containing both single- and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/QoL scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). Scores for each scale and single-item measure. A high score for functional scales and for Global Health Status/QoL, represent better functioning ability or HRQoL, whereas a high score for symptom scales and single items represents significant symptomatology.
Change from Baseline in HRQoL as measured by EORTC, 20-Item Multiple Myeloma Module (QLQ-MY20), Part 1 and 2
QLQ-MY20, module comprises 20 questions that address four myeloma-specific HRQoL domains: Disease Symptoms, Side Effects of Treatment (DSSE), Future Perspective, and Body Image (FPBI). Three of four QLQ-MY20 domains, are multi-item scales: Disease Symptoms (bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity); Side effects of treatment (drowsiness, thirst, feeling ill, dry mouth, hair loss, upset by hair loss, tingling hands or feet, restlessness/agitation, acid indigestion/heartburn, and burning or sore eyes); and Future perspective (worry about death and health in future, and thinking about illness). The Body Image scale is single-item scale that addresses physical attractiveness. A high score for DSSE, represents a high level of symptomatology or problems, whereas high score for FPBI, represents better outcomes.

Full Information

First Posted
April 30, 2018
Last Updated
May 22, 2023
Sponsor
GlaxoSmithKline
Collaborators
Iqvia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03544281
Brief Title
To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Acronym
DREAMM 6
Official Title
A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma - DREAMM-6
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
Collaborators
Iqvia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone [Len/Dex (Arm A)] or Bortezomib Plus Dexamethasone [Bor/Dex (Arm B)] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Part 1 of the study will be a dose escalation phase to evaluate the safety and tolerability of up to 3 dose levels and up to 2 dosing schedules of belantamab mafodotin in combination with the two standard of care (SoC) regimens. Part 2 will further evaluate the safety and preliminary clinical activity of belantamab mafodotin at selected dose levels and dosing schedules in combination with Len/Dex or Bor/Dex. A total of 152 evaluable participants will be enrolled in the study with up to 27 in Part 1 and up to 125 in Part 2. Participants receiving treatment Arm A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, death or end of study. The participants receiving treatment Arm B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with belantamab mafodotin, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Relapsed / Refractory Multiple Myeloma, Dose escalation, Antibody-Drug Conjugate, Dose expansion, belantamab mafodotin, Combination therapy, Belamaf

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
This is a 2-part study. Part 1 of the study will be a dose escalation phase to evaluate the safety and tolerability of up to 3 dose levels and up to 2 dosing schedules of belantamab mafodotin in combination with two SoC regimens (Arm A - belantamab mafodotin with Len/Dex and Arm B - belantamab mafodotin with Bor/Dex) For Arm A (belantamab mafodotin with Len/Dex), Part 2 of the study will further evaluate the safety and preliminary clinical activity of up to 2 dose levels and up to 3 dosing schedules of belantamab mafodotin with Len/Dex . For Arm B (belantamab mafodotin with Bor/Dex), Part 2 of the study will further evaluate the safety and preliminary clinical activity of up to 3 dose levels and up to 4 dosing schedules of belantamab mafodotin with Bor/Dex.
Masking
None (Open Label)
Masking Description
This is an open-label study; therefore, no blinding of treatment identity will be done for both treatments.
Allocation
Non-Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Belantamab mafodotin+lenalidomide +dexamethasone
Arm Type
Experimental
Arm Description
Participants will receive SINGLE full dose of belantamab mafodotin as 2.5 mg/kg and 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 min infusion. SPLIT: belantamab mafodotin will be administered in two equal divided doses, 2.5 mg/kg SPLIT dose of a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle. STRETCH: belantamab mafodotin will be administered as 1.9 mg/kg dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on.) Participants will also receive Lenalidomide 25 mg or 10 mg orally daily, on Days 1-21 of each 28 day cycle with Dexamethasone, 40 mg weekly per oral (PO)/intravenously (IV) on Days 1,8,15, & 22 of each cycle.
Arm Title
Arm B: Belantamab mafodotin+bortezomib+dexamethasone
Arm Type
Experimental
Arm Description
Participants will receive SINGLE full dose of belantamab mafodotin as 3.4 mg/kg; 2.5 mg/kg; 1.9 mg/kg on Day 1 of each 21-day cycle. SPLIT: belantamab mafodotin will be administered in two equal divided doses: 3.4 mg/kg SPLIT as 1.7 mg/kg dose on Day 1 & 1.7 mg/kg dose on Day 8; 2.5 mg/kg SPLIT dosing as 1.25 mg/kg dose on Day 1 & 1.25 mg/kg dose on Day 8 of each 21-day cycle. STRETCH: belantamab mafodotin will be administered as single dose of 2.5 mg/kg on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 & so on), 1.9 mg/kg administered on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 and so on). Step Down(S/D) STRETCH=belantamab mafodotin 2.5 mg/kg dose will be administered on Day 1 C1 followed by 1.9 mg/kg starting dose on Day1 of alternate 21-day cycles C3 onwards (C3,C5,C7, & so on). Bortezomib will be administered at 1.3 mg/m^2 SC/IV on Days 1,4,8, & 11 of every 21-day cycle. Dex will be administered at 20 mg PO or IV on Days 1,2,4,5,8,9,11, & 12 of every 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Belantamab mafodotin
Intervention Description
Selected doses of belantamab mafodotin will be administered as an infusion.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Lenalidomide will be administered as 25 or 10 mg,orally, with belantamab mafodotin and dexamethasone.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone will be administered as 20 or 40 mg, orally with belantamab mafodotin.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Bortezomib will be administered as 1.3 mg/m^2, as SC or IV, with belantamab mafodotin and dexamethasone.
Primary Outcome Measure Information:
Title
Number of participants with DLTs, Part 1, Treatment A
Description
The number of participants with DLTs will be reported.
Time Frame
Up to 28 days
Title
Number of participants with DLTs, Part 1, Treatment B
Description
The number of participants with DLTs will be reported.
Time Frame
Up to 21 days
Title
Number of participants with AEs and serious adverse events (SAEs), Part 1
Description
AEs and SAEs will be collected.
Time Frame
Up to 4.5 years
Title
Number of participants with electrocardiogram (ECG) parameters of potential clinical importance (PCI), Part 1
Description
Twelve-lead ECGs, will be performed, with the participant at designated time points, using an ECG machine, after 5 minutes of rest. The number of participants with PCI values, will be reported.
Time Frame
Up to 4.5 years
Title
Number of participants with abnormal hematology parameters, Part 1
Description
Blood sample will be collected for the assessment of hematology parameters.
Time Frame
Up to 4.5 years
Title
Number of participants with abnormal clinical chemistry parameters, Part 1
Description
Blood sample will be collected for the assessment of hematology parameters.
Time Frame
Up to 4.5 years
Title
Number of participants with abnormal urinalysis parameters, Part 1
Description
Urine samples will be collected for the assessment of urinalysis parameters.
Time Frame
Up to 4.5 years
Title
Number of participants with vital signs of PCI, Part 1
Description
Number of participants with abnormal vital signs will be assessed.
Time Frame
Up to 4.5 years
Title
Number of participants with AEs and SAEs in Part 2
Description
AEs and SAEs will be collected.
Time Frame
Up to 4.5 years
Title
Overall Response Rate (ORR) as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for multiple myeloma (MM), Part 2
Description
ORR defined as percentage (%) of participants achieving >=Partial Response (PR) as defined by the IMWG Uniform Response Criteria for MM.
Time Frame
Up to 4.5 years
Secondary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax) for belantamab mafodotin, Part 1 and 2, Treatment A
Description
Serial blood samples will be collected for pharmacokinetic (PK) analysis.
Time Frame
Cycle 1: Predose, at end of infusion, 2 hours, 24 hours after end of infusion, Day 4, Day 8 to Day 15, and Day 29 (cycle duration=28 days)
Title
Area under the concentration time curve (AUC) for belantamab mafodotin, Part 1 and 2, Treatment A
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Cycle 1: Predose, at end of infusion, 2 hours, 24 hours after end of infusion, Day 4, Day 8 to Day 15, and Day 29 (cycle duration=28 days)
Title
Time to maximum plasma concentration (Tmax) for belantamab mafodotin, Part 1 and 2, Treatment A
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Cycle 1: Predose, at end of infusion, 2 hours, 24 hours after end of infusion, Day 4, Day 8 to Day 15, and Day 29 (cycle duration=28 days)
Title
Serum half-life (t1/2) for belantamab mafodotin, Part 1 and 2, Treatment A
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Cycle 1: Predose, at end of infusion, 2 hours, 24 hours after end of infusion, Day 4, Day 8 to Day 15, and Day 29 (cycle duration=28 days)
Title
Cmax for belantamab mafodotin, Part 1 and 2, Treatment B
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Cycle 1: Predose, at end of infusion, 2 hours, 24 hours after end of infusion, Day 4, Day 11, and Day 22 (cycle duration=21 days)
Title
AUC for belantamab mafodotin, Part 1 and 2, Treatment B
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Cycle 1: Predose, at end of infusion, 2 hours, 24 hours after end of infusion, Day 4, Day 11, and Day 22 (cycle duration=21 days)
Title
Tmax for belantamab mafodotin, Part 1 and 2, Treatment B
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Cycle 1: Predose, at end of infusion, 2 hours, 24 hours after end of infusion, Day 4, Day 11, and Day 22 (cycle duration=21 days)
Title
t1/2 for belantamab mafodotin, Part 1 and 2, Treatment B
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Cycle 1: Predose, at end of infusion, 2 hours, 24 hours after end of infusion, Day 4, Day 11, and Day 22 (cycle duration=21 days)
Title
Cmax for Lenalidomide, Part 1 and 2, Treatment A
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Pre-dose, and 0.5, 1, 2, 4, and 24 hours post dose on Day 1 of Cycle 1 (cycle duration=28 days)
Title
AUC for Lenalidomide, Part 1 and 2, Treatment A
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Pre-dose, and 0.5, 1, 2, 4, and 24 hours post dose on Day 1 of Cycle 1 (cycle duration=28 days)
Title
Tmax for Lenalidomide, Part 1 and 2, Treatment A
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Pre-dose, and 0.5, 1, 2, 4, and 24 hours post dose on Day 1 of Cycle 1 (cycle duration=28 days)
Title
t1/2 for Lenalidomide, Part 1 and 2, Treatment A
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Pre-dose, and 0.5, 1, 2, 4, and 24 hours post dose on Day 1 of Cycle 1 (cycle duration=28 days)
Title
Cmax for Bortezomib, Part 1 and 2, Treatment B
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Pre-dose and 5, 15, 30 minutes and 1, 2, 4, 6, 10, 24, 48, 72 hours post-dose on Day 1 of Cycle 1 (cycle duration=21 days)
Title
AUC for Bortezomib, Part 1 and 2, Treatment B
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Pre-dose and 5, 15, 30 minutes and 1, 2, 4, 6, 10, 24, 48, 72 hours post-dose on Day 1 of Cycle 1 (cycle duration=21 days)
Title
Tmax for Bortezomib, Part 1 and 2, Treatment B
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Pre-dose and 5, 15, 30 minutes and 1, 2, 4, 6, 10, 24, 48, 72 hours post-dose on Day 1 of Cycle 1 (cycle duration=21 days)
Title
t1/2 for Bortezomib, Part 1 and 2, Treatment B
Description
Serial blood samples will be collected for PK analysis.
Time Frame
Pre-dose and 5, 15, 30 minutes and 1, 2, 4, 6, 10, 24, 48, 72 hours post-dose on Day 1 of Cycle 1 (cycle duration=21 days)
Title
Number of participants with anti-drug antibodies (ADAs) against belantamab mafodotin, Part 1 and 2, Treatment A
Description
The number of participants with ADAs will be assessed.
Time Frame
Pre-dose on Day 1 of Cycle 1, 2, 3, 6, 9, 12 (cycle duration=28 days)
Title
Number of participants with ADAs, against belantamab mafodotin, Part 1 and 2, treatment B
Description
The number of participants with ADAs will be assessed.
Time Frame
Pre-dose on Day 1 of Cycle 1, 2, 3, 6, 9, 12 (Cycle duration= 21 days)
Title
Change from Baseline in symptoms and impacts as measured by Ocular Surface Disease Index (OSDI), Part 1 and 2
Description
The OSDI, is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. The OSDI has demonstrated good reliability, validity, sensitivity, and specificity, and can be used as a complement to other clinical and subjective measures of dry eye disease by providing a quantifiable assessment of dry eye symptom frequency and the impact of these symptoms on vision-related functioning. The OSDI will be measured at every 4-weeks, for Treatment A and every 3-weeks, for Treatment B.
Time Frame
Baseline and up to 4.5 years
Title
Change from Baseline in symptoms and impacts as measured by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), Part 1 and 2
Description
The NEI-VFQ-25, consists of a base set of 25 vision-targeted questions representing, 11 vision-related constructs, plus an additional single-item, general health rating question. These include, a global vision rating (1 item); difficulty with near vision activities (3 items); difficulty with distance vision activities (3 items); limitations in social functioning due to vision (2 items); role limitations due to vision (2 items); dependency on others due to vision (3 items); mental health symptoms due to vision (4 items); driving difficulties (3 items); limitations with peripheral vision (1 item), limitations with color vision (1 item); and Ocular pain (2 items). Scores will be measured, every 4-weeks, for Treatment and every 3-weeks, for Treatment B.
Time Frame
Baseline and up to 4.5 years
Title
Change from Baseline in symptoms and impacts as measured by Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE), Part 1 and 2
Description
The PRO-CTCAE is a participant-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 80 symptomatic toxicities drawn from the CTCAE.
Time Frame
Baseline and up to 4.5 years
Title
Number of participants with AEs and SAEs, Part 2
Description
AEs and SAEs will be collected.
Time Frame
Up to 4.5 years
Title
Number of participants with AEs of special interest (AESI), Part 1 and 2
Description
The AEs of special interest will be collected.
Time Frame
Up to 4.5 years
Title
Number of participants with ophthalmic findings on ophthalmic exam, Part 1 and 2
Description
The ophthalmic examinations will be done, by an ophthalmologist (or optometrist), to assess participants who develop corneal events, during the study.
Time Frame
Up to 4.5 years
Title
Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30), Part 1 and 2
Description
EORTC QLQ-C30, is a 30-item questionnaire containing both single- and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/QoL scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). Scores for each scale and single-item measure. A high score for functional scales and for Global Health Status/QoL, represent better functioning ability or HRQoL, whereas a high score for symptom scales and single items represents significant symptomatology.
Time Frame
Baseline and Up to 4.5 years
Title
Change from Baseline in HRQoL as measured by EORTC, 20-Item Multiple Myeloma Module (QLQ-MY20), Part 1 and 2
Description
QLQ-MY20, module comprises 20 questions that address four myeloma-specific HRQoL domains: Disease Symptoms, Side Effects of Treatment (DSSE), Future Perspective, and Body Image (FPBI). Three of four QLQ-MY20 domains, are multi-item scales: Disease Symptoms (bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity); Side effects of treatment (drowsiness, thirst, feeling ill, dry mouth, hair loss, upset by hair loss, tingling hands or feet, restlessness/agitation, acid indigestion/heartburn, and burning or sore eyes); and Future perspective (worry about death and health in future, and thinking about illness). The Body Image scale is single-item scale that addresses physical attractiveness. A high score for DSSE, represents a high level of symptomatology or problems, whereas high score for FPBI, represents better outcomes.
Time Frame
Baseline and Up to 4.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Capable of giving signed informed consent. Male or female, 18 years or older (at the time consent is obtained). Have confirmed diagnosis of Multiple Myeloma (MM) as defined by the IMWG. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 for Arm A and 0 to 2 for Arm B. Have undergone stem cell transplant (SCT), or are considered transplant ineligible. Have been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy. Must have at least ONE aspect of measurable disease, defined as one the following: Urine M-protein excretion >=200 milligram (mg)/24 hours, or; Serum M-protein concentration >=0.5 gram (g)/deciliter (dL) (>=5.0 g/Liter), or; Serum free light chain (FLC) assay: involved FLC level >=10 mg/dL (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65). Participants with a history of autologous SCT, are eligible for study participation provided the following eligibility criteria are met: Autologous SCT was >100 days prior to study enrollment; No active bacterial, viral, or fungal infection(s) present; Participant meets the remainder of the eligibility criteria. All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 4.03, 2010) must be Grade <= 1 at the time of enrollment, except for alopecia. Participants with Grade 2 neuropathy can be enrolled into Len/Dex treatment arm, but not into Bor/Dex treatment arm. Adequate organ system functions as defined by the laboratory assessments. The contraceptions used by female participants be consistent with local regulations, regarding methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 4 months after the last dose of belantamab mafodotin and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. WOCBP Participants Assigned to Arm A: Due to lenalidomide being a thalidomide analogue with risk for embryo-fetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control (one method that is highly effective; beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment. Thereafter, WOCBP participants must use a contraceptive method that is highly effective (with a failure rate of <1% per year) for a further 3 months, and agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period: Two negative pregnancy tests must be obtained prior to initiating lenalidomide therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing lenalidomide therapy. WOCBP Participants Assigned to Arm B WOCBP assigned to Arm B must have a negative highly sensitive serum pregnancy test within 72 hours of dosing on C1D1 and agree to use effective contraception during the study and for 4 months after the last dose of belantamab mafodotin or 7 months from the last dose of bortezomib, whichever is longer. Male participants using contraception should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following: Arm A: from the time of first dose of study until 6 months after the last dose of belantamab mafodotin 4 weeks after the last dose of lenalidomide, whichever is longer, to allow for clearance of any altered sperm. Arm B: from the time of first dose of study until 6 months after the last dose of belantamab mafodotin or 4 months from the last dose of bortezomib (whichever is the longer) to allow for clearance of any altered sperm. Male participants must agree to refrain from donating sperm and either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below. Agree to use a male condom even if they have undergone a successful vasectomy and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse. Male participants should also use a condom with pregnant females. If the female partner of the male participant is pregnant at the time of enrollment, or becomes pregnant during the trial, the male participant must agree to remain abstinent (if it is consistent with their preferred and usual lifestyle) or use a male condom. Exclusion Criteria: Systemic anti-myeloma therapy (including systemic steroids) within <=14 days, or plasmapheresis within 7 days prior to the first dose of study drug. Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs. Prior allogenic stem cell transplant. Note: Participants who have undergone syngeneic transplant will be allowed only if they have no history and no currently active, graft versus host disease (GvHD). Evidence of active mucosal or internal bleeding. Any major surgery within the last four weeks. Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment). Participants with invasive malignancies other than multiple myeloma are excluded, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. Note: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction. Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system; Uncontrolled hypertension. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment. Pregnant or lactating female. Active infection requiring treatment. Known Human immunodeficiency virus (HIV) infection. Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at Screening or within 3 months prior to first dose of study treatment). Current corneal disease except for mild punctuate keratopathy. Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at Screening or within 3 months prior to first dose of study treatment. Current corneal disease except for mild punctute keratopathy. Participants Assigned to Treatment A (belantamab mafodotin plus Len/Dex): Participants unable to tolerate antithrombotic prophylaxis must be excluded; Discontinuation of prior treatment with lenalidomide due to intolerable AEs. Participants Assigned to Treatment B (belantamab mafodotin plus Bor/Dex): Unacceptable AEs from previous bortezomib treatment; Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain from previous bortezomib treatment; Intolerance or contraindications to anti-viral prophylaxis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
GSK Investigational Site
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-4200
Country
United States
Facility Name
GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
GSK Investigational Site
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
GSK Investigational Site
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
GSK Investigational Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
GSK Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
GSK Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
GSK Investigational Site
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
GSK Investigational Site
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
GSK Investigational Site
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
GSK Investigational Site
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
GSK Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
GSK Investigational Site
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
GSK Investigational Site
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
W1T 7HA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided, after a research proposal is submitted and has submitted approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided, for an initial period of 12 months but an extension can be granted, when justified for up to another 12 months.
IPD Sharing URL
http://clinicalstudydatarequest.com

Learn more about this trial

To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

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