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A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dara SC
Dara IV
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

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

Inclusion Criteria:

  • Evidence of a response (Partial response [PR] or better based on investigator's determination of response by international myeloma working group [IMWG] criteria) to at least 1 prior treatment regimen
  • Received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months). A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram/day [mg/day] for 4 days) would not be considered prior lines of therapy

  • Documented multiple myeloma as defined by the criteria below:

    1. Multiple myeloma diagnosis according to the IMWG diagnostic criteria

    2. Measurable disease at Screening as defined by any of the following:

      1. Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein level >=200 mg/24 hours; or
      2. Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Meet the clinical laboratory criteria as specified in the protocol
  • Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization

Exclusion Criteria:

  • Received daratumumab or other anti-CD38 therapies previously
  • Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) before treatment
  • Received autologous stem cell transplant within 12 weeks before the date of randomization, or the participant has previously received allogeneic stem cell transplant (regardless of timing)
  • Plans to undergo a stem cell transplant prior to progression of disease on this study (these participants should not be enrolled to reduce disease burden prior to transplant)
  • History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease. Further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years

Sites / Locations

  • Dana-Farber Cancer Institute
  • Levine Cancer Institute
  • Royal Prince Alfred Hospital
  • St. Vincent's Hospital Melbourne
  • Alfred Health
  • Fiona Stanley Hospital
  • Sir Charles Gairdner Hospital
  • Calvary Mater Newcastle Hospital
  • The Queen Elizabeth Hospital
  • Princess Alexandra Hospital
  • Fundacao Pio XII
  • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
  • Fundacao Doutor Amaral Carvalho
  • Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia
  • Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
  • Hospital das Clinicas de Porto Alegre
  • Instituto de Educacao, Pesquisa e Gestao em Saude
  • CEHON
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
  • Clinica Sao Germano
  • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • The Gordon & Leslie Diamond Health Care Center
  • QEII Health Sciences Centre
  • Victoria Hospital
  • Princess Margaret Hospital
  • CHU de Québec -L'Hôtel-Dieu de Québec
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Hradec Kralove
  • Fakultní nemocnice Olomouc
  • Fakultni nemocnice Ostrava
  • Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
  • Fakultni nemocnice Kralovske Vinohrady
  • Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
  • CHU Caen - Côte de Nacre
  • Hopital Claude Huriez
  • CHU de Nantes hotel-Dieu
  • CHU de Boreaux
  • Centre hospitalier Lyon-Sud
  • CHU Poitiers - Hôpital la Milétrie
  • CHU Nancy Brabois
  • Alexandra General Hospital of Athens
  • Hillel Yaffe Medical Center - Oncology
  • Rambam Med.Center - Hematology Institute
  • Carmel Medical Center
  • Hadassah Medical Center
  • Rabin Medical Center, Beilinson Campus
  • Sheba Medical Center Tel Hashomer
  • Tel Aviv Sourasky Medical Center
  • Policlinico Sant'Orsola Malpighi
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Ospedale Villa Sofia-Cervello
  • Fondazione IRCCS Policlinico San Matteo
  • Azienda USL di Piacenza
  • Università di Roma La Sapienza
  • Policlinico Universitario Agostino Gemelli
  • A.O.U. Città della Salute e della Scienza
  • Fukuoka University Hospital
  • Chugoku Central Hospital
  • Ogaki Municipal Hospital
  • Gunma University Hospital
  • Kobe City Medical Center General Hospital
  • Iwate Medical University Hospital
  • University Hospital Kyoto Perfectural University of Medicine
  • Matsuyama Red Cross Hospital
  • Japanese Red Cross Nagoya Daini Hospital
  • Nagoya City University Hospital
  • Niigata Cancer Center Hospital
  • National Hospital Organization Okayama Medical Center
  • Osaka University Hospital
  • National Hospital Organization Sendai Medical Center
  • National Hospital Organization Shibukawa Medical Center
  • Japanese Red Cross Medical Center
  • Pusan National University Hospital
  • National Cancer Center
  • Gachon University Gil Medical Center
  • Severance Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • The Catholic University of Korea Seoul St. Mary's Hospital
  • Ulsan University Hospital
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
  • Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
  • Szpitale Pomorskie Sp. z o.o.
  • Szpital Uniwersytecki w Krakowie
  • Wojewodzki Szpital Specjalistyczny w Legnicy
  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
  • Emergency Hospital of Dzerzhinsk
  • Ekaterinburg City Clinical Hospital # 7
  • S.P. Botkin Moscow City Clinical Hospital
  • City Clinical Hospital # 40
  • Nizhniy Novgorod Region Clinical Hospital
  • Penza Regional Oncology Dispensary
  • Ryazan Regional Clinical Hospital
  • Saint Petersburg City Hospital #15
  • Samara Region Clinical Hospital
  • Clinical Research Institute of Hematology and Transfusiology
  • Oncology Dispensary of Komi Republic
  • Hosp. Univ. Germans Trias I Pujol
  • Hosp. Clinic I Provincial de Barcelona
  • Hosp. Univ. Dr. Josep Trueta
  • Hosp. Univ. Virgen de Las Nieves
  • Hosp. Univ. de Canarias
  • Hosp. de Leon
  • Hosp. Gral. Univ. Gregorio Maranon
  • Hosp. Univ. Infanta Leonor
  • Hosp. Univ. 12 de Octubre
  • Clinica Univ. de Navarra
  • Hosp. Quiron Madrid Pozuelo
  • Hosp. Clinico Univ. de Salamanca
  • Hosp. Univ. Dr. Peset
  • Falu Lasarett
  • Helsingborgs lasarett
  • Karolinska University Hospital, Huddinge
  • Skanes universitetssjukhus
  • Norrlands University Hospital
  • Akademiska Sjukhuset
  • Chang-Hua Christian Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital
  • Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
  • Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
  • Ivano-Frankivsk Regional Clinical Hospital
  • SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine
  • National Cancer Institute, Dept. of chemotherapy of hemoblastosis
  • Kiev Marrow Transplantation Center, Bone Marrow Transplantation Department
  • State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine'
  • Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine
  • Mykolaiv Regional Clinical Hospital
  • Ukrainian Medical Stomatological Academy, Poltava Regional Clinical Hospital
  • Blackpool Victoria Hospital
  • Royal Bournemouth Hospital
  • Leicester Royal Infirmary - Haematology
  • St Bartholomew's Hospital
  • Guy's & St Thomas Hospital
  • Christie Hospital NHS Trust
  • Nottingham City Hospital
  • Royal Marsden Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dara SC

Dara IV

Arm Description

Participants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks.

Participants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks. For Participants still receiving treatment with Dara-IV at the time of Protocol Amendment 4 the duration of infusion may be shortened to a 90-minute infusion or participants will have the option to switch to Dara 1800 mg subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligram (mg)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels were required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, >=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas was also required.
Maximum Trough Concentration (Ctrough) of Daratumumab
Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.

Secondary Outcome Measures

Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)
Percentage of participants with treatment-emergent infusion-related reactions were reported.
Progression Free Survival (PFS)
PFS was defined as time from date of randomization to either progression of disease (PD), death due to any cause, whichever occurs first. IMWG criteria for PD: Increase of 25% from lowest response value in any one of the following: Serum M component (absolute increase must be >=0.5 grams per deciliter (g/dL), Urine M-component (absolute increase must be >=200 mg/24 hours), Participants without measurable serum and urine Mprotein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be >10 milligrams per deciliter (mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Percentage of Participants With Very Good Partial Response (VGPR) or Better
VGPR or better was defined as the percentage of participants who achieved VGPR or better (VGPR, complete response (CR) or stringent complete response [sCR]), based on computerized algorithm as per IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligrams (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cellS (PCs) in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescencea or 2- to 4 color flow cytometry.
Percentage of Participants With Complete Response (Including sCR) or Better
CR or better was defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. IMWG criteria for CR- negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by IHC, immunofluorescencea or 2- to 4 color flow cytometry.
Time to Next Therapy
Time to next therapy was defined as the time from randomization to the start of the first subsequent anti-cancer therapy.
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.
Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)
Modified-CTSQ contain 9 items (2 items for Thoughts about Cancer Therapy and 7 items in a defined domain of Satisfaction with Therapy) specific to satisfaction with therapy and for comparison of SC and IV administration. Satisfaction with therapy was calculated based on 7-items using 5-point verbal rating scale, where 1= never and 5= always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health. At least 5 of the 7 items within the Satisfaction with Therapy domain had to be completed to calculate a domain score. No domain score was calculated for Thoughts about Cancer Therapy.
Duration of Response
Duration of response was defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG criteria. PD was defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Time to Partial Response (PR) or Better
Time to PR or better was defined as the time from randomization until onset of first response of PR or better.
Time to Very Good Partial Response (VGPR) or Better
Time to VGPR or better was defined as the time from randomization until onset of first VGPR or better.
Time to Complete Response (CR) or Better
Time to CR or better was defined as the time from randomization until onset of first CR or better.

Full Information

First Posted
September 7, 2017
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03277105
Brief Title
A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma
Official Title
A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
June 27, 2019 (Actual)
Study Completion Date
December 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).
Detailed Description
The study population will consist of adults diagnosed with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease is refractory to both a PI and an IMiD. The study consists of 3 phases: a screening phase (up to 28 days), a treatment phase, and a follow-up phase. Efficacy, pharmacokinetics, immunogenicity, biomarkers and safety will be assessed at scheduled time. Follow-up will continue until the end of the data collection period, approximately 24 months after the last participant was randomized or when the median overall survival for both arms has been reached, whichever occurs first. The primary hypotheses is that the ORR and maximum Ctrough for Dara SC 1800 milligram (mg) are not inferior to the ORR and maximum Ctrough, respectively, for Dara IV 16 mg per kilogram (mg/kg) in participants with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease is refractory to both a PI and an IMiD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
522 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dara SC
Arm Type
Experimental
Arm Description
Participants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks.
Arm Title
Dara IV
Arm Type
Active Comparator
Arm Description
Participants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks. For Participants still receiving treatment with Dara-IV at the time of Protocol Amendment 4 the duration of infusion may be shortened to a 90-minute infusion or participants will have the option to switch to Dara 1800 mg subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.
Intervention Type
Drug
Intervention Name(s)
Dara SC
Intervention Description
Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
Intervention Type
Drug
Intervention Name(s)
Dara IV
Other Intervention Name(s)
JNJ-54767414
Intervention Description
Participants will receive Dara IV 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligram (mg)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels were required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, >=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas was also required.
Time Frame
Up to 2 years
Title
Maximum Trough Concentration (Ctrough) of Daratumumab
Description
Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.
Time Frame
Predose on Cycle 3 Day 1 (each cycle of 28 days)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)
Description
Percentage of participants with treatment-emergent infusion-related reactions were reported.
Time Frame
Up to 2 years
Title
Progression Free Survival (PFS)
Description
PFS was defined as time from date of randomization to either progression of disease (PD), death due to any cause, whichever occurs first. IMWG criteria for PD: Increase of 25% from lowest response value in any one of the following: Serum M component (absolute increase must be >=0.5 grams per deciliter (g/dL), Urine M-component (absolute increase must be >=200 mg/24 hours), Participants without measurable serum and urine Mprotein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be >10 milligrams per deciliter (mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Time Frame
Up to 2 years
Title
Percentage of Participants With Very Good Partial Response (VGPR) or Better
Description
VGPR or better was defined as the percentage of participants who achieved VGPR or better (VGPR, complete response (CR) or stringent complete response [sCR]), based on computerized algorithm as per IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligrams (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cellS (PCs) in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescencea or 2- to 4 color flow cytometry.
Time Frame
Up to 2 years
Title
Percentage of Participants With Complete Response (Including sCR) or Better
Description
CR or better was defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. IMWG criteria for CR- negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by IHC, immunofluorescencea or 2- to 4 color flow cytometry.
Time Frame
Up to 2 years
Title
Time to Next Therapy
Description
Time to next therapy was defined as the time from randomization to the start of the first subsequent anti-cancer therapy.
Time Frame
Up to 2 years
Title
Overall Survival (OS)
Description
OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.
Time Frame
Up to 2 years
Title
Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)
Description
Modified-CTSQ contain 9 items (2 items for Thoughts about Cancer Therapy and 7 items in a defined domain of Satisfaction with Therapy) specific to satisfaction with therapy and for comparison of SC and IV administration. Satisfaction with therapy was calculated based on 7-items using 5-point verbal rating scale, where 1= never and 5= always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health. At least 5 of the 7 items within the Satisfaction with Therapy domain had to be completed to calculate a domain score. No domain score was calculated for Thoughts about Cancer Therapy.
Time Frame
Cycle 1 (Days 8,15 and 22), Cycle 2 (Days 1,8,15 and 22), Cycle 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 22 (Day 1)
Title
Duration of Response
Description
Duration of response was defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG criteria. PD was defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Time Frame
Up to 2 years
Title
Time to Partial Response (PR) or Better
Description
Time to PR or better was defined as the time from randomization until onset of first response of PR or better.
Time Frame
Up to 2 years
Title
Time to Very Good Partial Response (VGPR) or Better
Description
Time to VGPR or better was defined as the time from randomization until onset of first VGPR or better.
Time Frame
Up to 2 years
Title
Time to Complete Response (CR) or Better
Description
Time to CR or better was defined as the time from randomization until onset of first CR or better.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Evidence of a response (Partial response [PR] or better based on investigator's determination of response by international myeloma working group [IMWG] criteria) to at least 1 prior treatment regimen Received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months). A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram/day [mg/day] for 4 days) would not be considered prior lines of therapy Documented multiple myeloma as defined by the criteria below: Multiple myeloma diagnosis according to the IMWG diagnostic criteria Measurable disease at Screening as defined by any of the following: Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein level >=200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 Meet the clinical laboratory criteria as specified in the protocol Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization Exclusion Criteria: Received daratumumab or other anti-CD38 therapies previously Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) before treatment Received autologous stem cell transplant within 12 weeks before the date of randomization, or the participant has previously received allogeneic stem cell transplant (regardless of timing) Plans to undergo a stem cell transplant prior to progression of disease on this study (these participants should not be enrolled to reduce disease burden prior to transplant) History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease. Further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5418
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Alfred Health
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Calvary Mater Newcastle Hospital
City
Waratah
ZIP/Postal Code
2298
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
ZIP/Postal Code
5011
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Fundacao Pio XII
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
City
Florianopolis
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Fundacao Doutor Amaral Carvalho
City
Jau
ZIP/Postal Code
17210-080
Country
Brazil
Facility Name
Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia
City
Joinville
ZIP/Postal Code
89201-260
Country
Brazil
Facility Name
Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
City
Passo Fundo
ZIP/Postal Code
99010-090
Country
Brazil
Facility Name
Hospital das Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Instituto de Educacao, Pesquisa e Gestao em Saude
City
Rio de Janeiro
ZIP/Postal Code
22775-001
Country
Brazil
Facility Name
CEHON
City
Salvador
ZIP/Postal Code
45995-000
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Clinica Sao Germano
City
São Paulo
ZIP/Postal Code
01455-010
Country
Brazil
Facility Name
Hospital Das Clinicas Da Faculdade De Medicina Da USP
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
The Gordon & Leslie Diamond Health Care Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X6
Country
Canada
Facility Name
CHU de Québec -L'Hôtel-Dieu de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultní nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
City
Plzen
ZIP/Postal Code
323 00
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
CHU Caen - Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Claude Huriez
City
Lille Cedex
ZIP/Postal Code
59000
Country
France
Facility Name
CHU de Nantes hotel-Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Boreaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre hospitalier Lyon-Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Poitiers - Hôpital la Milétrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU Nancy Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Alexandra General Hospital of Athens
City
Athens Attica
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Hillel Yaffe Medical Center - Oncology
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Rambam Med.Center - Hematology Institute
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Ospedale Villa Sofia-Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda USL di Piacenza
City
Piacenza
ZIP/Postal Code
29121
Country
Italy
Facility Name
Università di Roma La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
A.O.U. Città della Salute e della Scienza
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Chugoku Central Hospital
City
Fukuyama
ZIP/Postal Code
720-0001
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Gunma University Hospital
City
Gunma
ZIP/Postal Code
371-0034
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
University Hospital Kyoto Perfectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Matsuyama Red Cross Hospital
City
Matsuyama
ZIP/Postal Code
790-8524
Country
Japan
Facility Name
Japanese Red Cross Nagoya Daini Hospital
City
Nagoya
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai-City
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
National Hospital Organization Shibukawa Medical Center
City
Shibukawa
ZIP/Postal Code
377-0280
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-Si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o.
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny w Legnicy
City
Legnica
ZIP/Postal Code
59-220
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Emergency Hospital of Dzerzhinsk
City
Dzerzhinsk
ZIP/Postal Code
606019
Country
Russian Federation
Facility Name
Ekaterinburg City Clinical Hospital # 7
City
Ekaterinburg
ZIP/Postal Code
620137
Country
Russian Federation
Facility Name
S.P. Botkin Moscow City Clinical Hospital
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
City Clinical Hospital # 40
City
Moscow
ZIP/Postal Code
129301
Country
Russian Federation
Facility Name
Nizhniy Novgorod Region Clinical Hospital
City
Nizny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Penza Regional Oncology Dispensary
City
Penza
ZIP/Postal Code
440071
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Hospital
City
Ryazan
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Saint Petersburg City Hospital #15
City
Saint-Petersburg
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Samara Region Clinical Hospital
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Clinical Research Institute of Hematology and Transfusiology
City
St-Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Oncology Dispensary of Komi Republic
City
Syktyvkar
ZIP/Postal Code
167904
Country
Russian Federation
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hosp. Univ. Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hosp. Univ. Virgen de Las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hosp. Univ. de Canarias
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hosp. de Leon
City
Leon
ZIP/Postal Code
24008
Country
Spain
Facility Name
Hosp. Gral. Univ. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hosp. Univ. Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hosp. Quiron Madrid Pozuelo
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hosp. Univ. Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Falu Lasarett
City
Falun
ZIP/Postal Code
79182
Country
Sweden
Facility Name
Helsingborgs lasarett
City
Helsingborg
ZIP/Postal Code
25187
Country
Sweden
Facility Name
Karolinska University Hospital, Huddinge
City
Huddinge
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Skanes universitetssjukhus
City
Lund
ZIP/Postal Code
222 41
Country
Sweden
Facility Name
Norrlands University Hospital
City
Umea
ZIP/Postal Code
907 46
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
Chang-Hua Christian Hospital
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung,
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
City
Dnepropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Clinical Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine
City
Kharkiv
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
National Cancer Institute, Dept. of chemotherapy of hemoblastosis
City
Kiev
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Kiev Marrow Transplantation Center, Bone Marrow Transplantation Department
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine'
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Mykolaiv Regional Clinical Hospital
City
Mykolaiv
ZIP/Postal Code
54000
Country
Ukraine
Facility Name
Ukrainian Medical Stomatological Academy, Poltava Regional Clinical Hospital
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Blackpool Victoria Hospital
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Leicester Royal Infirmary - Haematology
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Guy's & St Thomas Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Christie Hospital NHS Trust
City
Manchester
ZIP/Postal Code
M20 9BX
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35354247
Citation
Usmani SZ, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis NJ, Flogegard M, Blade J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Lantz K, O'Rourke L, Heuck C, Delioukina M, Qin X, Nnane I, Qi M, Mateos MV. Final analysis of the phase III non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma. Haematologica. 2022 Oct 1;107(10):2408-2417. doi: 10.3324/haematol.2021.279459.
Results Reference
derived
PubMed Identifier
33599794
Citation
Iida S, Ishikawa T, Min CK, Kim K, Yeh SP, Usmani SZ, Mateos MV, Nahi H, Heuck C, Qin X, Parasrampuria DA, Gries KS, Qi M, Bahlis N, Ito S. Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study. Ann Hematol. 2021 Apr;100(4):1065-1077. doi: 10.1007/s00277-021-04405-2. Epub 2021 Feb 18.
Results Reference
derived
PubMed Identifier
32852632
Citation
Usmani SZ, Mateos MV, Hungria V, Iida S, Bahlis NJ, Nahi H, Magen H, Cavo M, Hulin C, White D, De Stefano V, Fastenau J, Slavcev M, Heuck C, Qin X, Pei H, Masterson T, Lantz K, Gries KS. Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results. J Cancer Res Clin Oncol. 2021 Feb;147(2):619-631. doi: 10.1007/s00432-020-03365-w. Epub 2020 Aug 27.
Results Reference
derived
PubMed Identifier
32213342
Citation
Mateos MV, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis N, Flogegard M, Blade J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Clemens PL, Masterson T, Lantz K, O'Rourke L, Heuck C, Qin X, Parasrampuria DA, Yuan Z, Xu S, Qi M, Usmani SZ. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020 May;7(5):e370-e380. doi: 10.1016/S2352-3026(20)30070-3. Epub 2020 Mar 23. Erratum In: Lancet Haematol. 2020 Oct;7(10):e710.
Results Reference
derived

Learn more about this trial

A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma

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