search
Back to results

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 7)

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Belantamab mafodotin
Daratumumab
Bortezomib
Dexamethasone
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 Belantamab mafodotin, Relapsed/refractory multiple myeloma, Daratumumab, Bortezomib, Dexamethasone, Multiple Myeloma

Eligibility Criteria

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

Inclusion Criteria:

  • Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria.
  • Previously treated with at least 1 prior line of multiple myeloma (MM) therapy, and must have documented disease progression during or after their most recent therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

  • Must have at least 1 aspect of measurable disease, defined as one of the following;

    1. Urine M-protein excretion >=200 mg per 24-hour, or
    2. Serum M-protein concentration >=0.5 grams per deciliter (g/dL), or
    3. Serum free light chain (FLC) assay: involved FLC level >=10 mg per dL (>=100 mg per liter) and an abnormal serum free light chain ratio (<0.26 or >1.65).
  • All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be <=Grade 1 at the time of enrollment, except for alopecia.
  • Adequate organ function

Exclusion Criteria:

  • Intolerant to daratumumab.
  • Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment).
  • Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed.
  • Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.
  • Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy.
  • Prior allogenic stem cell transplant.
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies.
  • Corneal epithelial disease.

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
  • 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
  • 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
  • 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
  • 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
  • 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

Active Comparator

Arm Label

Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)

Daratumumab and Bortezomib plus Dexamethasone (Arm B)

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival
Time from the date of randomization until the earliest date of to the first documented disease progression or death due to any cause, whichever occurs first

Secondary Outcome Measures

Complete response rate (CRR)
Percentage of participants with a confirmed complete response or better.
Overall response rate (ORR)
Percentage of participants with a confirmed partial response or better.
Clinical Benefit Rate (CBR)
Percentage of participants with a confirmed partial response or better
Duration of response (DoR)
Time from first documented evidence of partial response or better to date of first documented progression or death, whichever occurs first.
Time to response (TTR)
Time from the date of randomization and the first documented evidence of response among participants who achieve partial response or better.
Time to Progression (TTP)
Time from the date of randomization until the first documented date of disease progression or death, whichever occurs first.
Overall survival (OS)
Time from randomization to death due to any cause.
Progression-free survival on subsequent line of therapy (PFS2)
Time from start of study treatment to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever occurs first. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier .
Minimal Residual Disease (MRD) negativity rate
Percentage of participants who are MRD negative by next-generation sequencing.
Number of participants with adverse events (AEs)
AEs will be collected, including abnormal laboratory parameters.
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Number of participants with abnormal ocular findings on ophthalmic examination
Ophthalmic examination will assess abnormal findings.
Plasma concentrations of belantamab mafodotin at indicated time points
Plasma concentrations of belantamab mafodotin in Arm A.
Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points
Plasma concentrations of cys-mcMMAF in Arm A.
Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
Plasma concentrations of belantamab mafodotin ADAs in Arm A.
Titers of ADAs against belantamab mafodotin
Titers of ADAs in Arm A.
Number of Participants with Maximum post-baseline change from baseline in individual items of Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE)
PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score..
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)
EORTC Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.
Change from Baseline in HRQoL as measured by EORTC IL52, 20-Item Multiple Myeloma Module (QLQ-MY20)
EORTC IL52 Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.

Full Information

First Posted
January 27, 2020
Last Updated
June 13, 2023
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT04246047
Brief Title
Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Acronym
DREAMM 7
Official Title
DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 7, 2020 (Actual)
Primary Completion Date
September 26, 2023 (Anticipated)
Study Completion Date
June 19, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

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
This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Belantamab mafodotin, Relapsed/refractory multiple myeloma, Daratumumab, Bortezomib, Dexamethasone, Multiple Myeloma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)
Arm Type
Experimental
Arm Title
Daratumumab and Bortezomib plus Dexamethasone (Arm B)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Belantamab mafodotin
Intervention Description
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Intervention Description
Anti-cluster of differentiation 38 [CD-38] monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Proteasome Inhibitor
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Synthetic glucocorticoid with anti-tumor activity
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Time from the date of randomization until the earliest date of to the first documented disease progression or death due to any cause, whichever occurs first
Time Frame
Up to an average of 34 months
Secondary Outcome Measure Information:
Title
Complete response rate (CRR)
Description
Percentage of participants with a confirmed complete response or better.
Time Frame
Up to 74 months
Title
Overall response rate (ORR)
Description
Percentage of participants with a confirmed partial response or better.
Time Frame
Up to 74 months
Title
Clinical Benefit Rate (CBR)
Description
Percentage of participants with a confirmed partial response or better
Time Frame
Up to 74 months
Title
Duration of response (DoR)
Description
Time from first documented evidence of partial response or better to date of first documented progression or death, whichever occurs first.
Time Frame
Up to 74 months
Title
Time to response (TTR)
Description
Time from the date of randomization and the first documented evidence of response among participants who achieve partial response or better.
Time Frame
Up to 74 months
Title
Time to Progression (TTP)
Description
Time from the date of randomization until the first documented date of disease progression or death, whichever occurs first.
Time Frame
Up to 74 months
Title
Overall survival (OS)
Description
Time from randomization to death due to any cause.
Time Frame
Up to 74 months
Title
Progression-free survival on subsequent line of therapy (PFS2)
Description
Time from start of study treatment to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever occurs first. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier .
Time Frame
Up to 74 months
Title
Minimal Residual Disease (MRD) negativity rate
Description
Percentage of participants who are MRD negative by next-generation sequencing.
Time Frame
Up to 74 months
Title
Number of participants with adverse events (AEs)
Description
AEs will be collected, including abnormal laboratory parameters.
Time Frame
Up to 74 months
Title
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Time Frame
Up to 74 months
Title
Number of participants with abnormal ocular findings on ophthalmic examination
Description
Ophthalmic examination will assess abnormal findings.
Time Frame
Up to 74 months
Title
Plasma concentrations of belantamab mafodotin at indicated time points
Description
Plasma concentrations of belantamab mafodotin in Arm A.
Time Frame
Up to 74 months
Title
Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points
Description
Plasma concentrations of cys-mcMMAF in Arm A.
Time Frame
Up to 74 months
Title
Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
Description
Plasma concentrations of belantamab mafodotin ADAs in Arm A.
Time Frame
Up to 74 months
Title
Titers of ADAs against belantamab mafodotin
Description
Titers of ADAs in Arm A.
Time Frame
Up to 74 months
Title
Number of Participants with Maximum post-baseline change from baseline in individual items of Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE)
Description
PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score..
Time Frame
Up to 74 months
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)
Description
EORTC Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.
Time Frame
Baseline and Up to 74 months
Title
Change from Baseline in HRQoL as measured by EORTC IL52, 20-Item Multiple Myeloma Module (QLQ-MY20)
Description
EORTC IL52 Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.
Time Frame
Baseline and Up to 74 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria. Previously treated with at least 1 prior line of multiple myeloma (MM) therapy, and must have documented disease progression during or after their most recent therapy. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Must have at least 1 aspect of measurable disease, defined as one of the following; Urine M-protein excretion >=200 mg per 24-hour, or Serum M-protein concentration >=0.5 grams per deciliter (g/dL), or Serum free light chain (FLC) assay: involved FLC level >=10 mg per dL (>=100 mg per liter) and an abnormal serum free light chain ratio (<0.26 or >1.65). All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be <=Grade 1 at the time of enrollment, except for alopecia. Adequate organ function Exclusion Criteria: Intolerant to daratumumab. Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment). Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed. Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain. Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy. Prior allogenic stem cell transplant. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies. Corneal epithelial disease.
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
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Facility Name
GSK Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
GSK Investigational Site
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
GSK Investigational Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
GSK Investigational Site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
GSK Investigational Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
GSK Investigational Site
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
GSK Investigational Site
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
GSK Investigational Site
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
GSK Investigational Site
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
GSK Investigational Site
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
GSK Investigational Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
GSK Investigational Site
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
GSK Investigational Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
GSK Investigational Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
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
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
GSK Investigational Site
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
GSK Investigational Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
GSK Investigational Site
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
GSK Investigational Site
City
Joinville
State/Province
Santa Catarina
ZIP/Postal Code
89201-260
Country
Brazil
Facility Name
GSK Investigational Site
City
Rio de Janeiro
ZIP/Postal Code
22775001
Country
Brazil
Facility Name
GSK Investigational Site
City
São Paulo
ZIP/Postal Code
04537-080
Country
Brazil
Facility Name
GSK Investigational Site
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
GSK Investigational Site
City
Québec
State/Province
Ontario
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
GSK Investigational Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
GSK Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
GSK Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
GSK Investigational Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
GSK Investigational Site
City
Jianan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
GSK Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
GSK Investigational Site
City
GuangZhou
ZIP/Postal Code
510515
Country
China
Facility Name
GSK Investigational Site
City
Jiang Su Province
ZIP/Postal Code
215006
Country
China
Facility Name
GSK Investigational Site
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
GSK Investigational Site
City
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
GSK Investigational Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
GSK Investigational Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
GSK Investigational Site
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
GSK Investigational Site
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
GSK Investigational Site
City
Amiens cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
GSK Investigational Site
City
Caen cedex 9
ZIP/Postal Code
14033
Country
France
Facility Name
GSK Investigational Site
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
GSK Investigational Site
City
Paris cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
GSK Investigational Site
City
Rennes cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
GSK Investigational Site
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
GSK Investigational Site
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
GSK Investigational Site
City
Duesseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
GSK Investigational Site
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
GSK Investigational Site
City
Alexandroupolis
ZIP/Postal Code
68 100
Country
Greece
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
GSK Investigational Site
City
Thessaloniki
ZIP/Postal Code
54007
Country
Greece
Facility Name
GSK Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
GSK Investigational Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
GSK Investigational Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
GSK Investigational Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
GSK Investigational Site
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
GSK Investigational Site
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
GSK Investigational Site
City
Ravenna
State/Province
Emilia-Romagna
ZIP/Postal Code
48123
Country
Italy
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
GSK Investigational Site
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
GSK Investigational Site
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
GSK Investigational Site
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
GSK Investigational Site
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
GSK Investigational Site
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
GSK Investigational Site
City
Aichi
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
GSK Investigational Site
City
Aichi
ZIP/Postal Code
446-8602
Country
Japan
Facility Name
GSK Investigational Site
City
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
GSK Investigational Site
City
Aomori
ZIP/Postal Code
030-8553
Country
Japan
Facility Name
GSK Investigational Site
City
Chiba
ZIP/Postal Code
296-8602
Country
Japan
Facility Name
GSK Investigational Site
City
Ehime
ZIP/Postal Code
790-8524
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
806-8501
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
815-8555
Country
Japan
Facility Name
GSK Investigational Site
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
GSK Investigational Site
City
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
GSK Investigational Site
City
Gunma
ZIP/Postal Code
377-0280
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
GSK Investigational Site
City
Hyogo
ZIP/Postal Code
670-8540
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
221-0855
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
GSK Investigational Site
City
Kochi
ZIP/Postal Code
781-8555
Country
Japan
Facility Name
GSK Investigational Site
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
GSK Investigational Site
City
Nagano
ZIP/Postal Code
392-8510
Country
Japan
Facility Name
GSK Investigational Site
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
530-0012
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
GSK Investigational Site
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
GSK Investigational Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seongnam-si, Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
GSK Investigational Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
GSK Investigational Site
City
Dunedin
ZIP/Postal Code
9054
Country
New Zealand
Facility Name
GSK Investigational Site
City
Newtown
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
GSK Investigational Site
City
Takapuna, Auckland
ZIP/Postal Code
1309
Country
New Zealand
Facility Name
GSK Investigational Site
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
30510
Country
Poland
Facility Name
GSK Investigational Site
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
GSK Investigational Site
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
GSK Investigational Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
GSK Investigational Site
City
Nowy Sacz
ZIP/Postal Code
33-300
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Samara
ZIP/Postal Code
443021
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St'Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
197 089
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ufa
ZIP/Postal Code
450083
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
GSK Investigational Site
City
Gijón
ZIP/Postal Code
33394
Country
Spain
Facility Name
GSK Investigational Site
City
Hospitalet de Llobregat (Barcelona)
ZIP/Postal Code
08908
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
GSK Investigational Site
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
GSK Investigational Site
City
Móstoles
ZIP/Postal Code
28933
Country
Spain
Facility Name
GSK Investigational Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
GSK Investigational Site
City
Pozuelo De Alarcón/Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
GSK Investigational Site
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
GSK Investigational Site
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
W12 0NN
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 received 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

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

We'll reach out to this number within 24 hrs