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)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Belantamab mafodotin; Drug: Bortezomib; Drug: Dexamethasone; Drug: Daratumumab

Detailed Description

Approximately 478 participants will be randomized 1:1 to Arm A (B-Vd) or Arm B (D-Vd). Treatment will continue in both arms until progressive disease, death, unacceptable toxicity, withdrawal of consent or end of study, whichever occurs first.

• Study Type: Interventional
• Enrollment (Actual): 494
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • GSK Investigational Site
    • Wollongong, New South Wales, Australia, 2500
      • GSK Investigational Site
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • GSK Investigational Site
• Belgium
  • Brussels, Belgium, 1200
    • GSK Investigational Site
  • Brussels, Belgium, 1090
    • GSK Investigational Site
  • Ghent, Belgium, 9000
    • GSK Investigational Site
  • Roeselare, Belgium, 8800
    • GSK Investigational Site
• China
  • Beijing, China, 100191
    • GSK Investigational Site
  • Jinan, China, 250012
    • GSK Investigational Site
  • Shenyang, China, 110001
    • GSK Investigational Site
• Greece
  • Alexandroupoli, Greece, 68 100
    • GSK Investigational Site
  • Athens, Greece, 11528
    • GSK Investigational Site
  • Thessaloniki, Greece, 54007
    • GSK Investigational Site
• Israel
  • Tel Aviv, Israel, 64239
    • GSK Investigational Site
• Italy
  • Bergamo, Italy, 24127
    • GSK Investigational Site
  • Meldola FC, Italy, 47014
    • GSK Investigational Site
  • Milan, Italy, 20133
    • GSK Investigational Site
  • Siena, Italy, 53100
    • GSK Investigational Site
• Japan
  • Aichi, Japan, 467-8602
    • GSK Investigational Site
  • Aichi, Japan, 441-8570
    • GSK Investigational Site
  • Aomori, Japan, 030-8553
    • GSK Investigational Site
  • Ehime, Japan, 790-8524
    • GSK Investigational Site
  • Fukuoka, Japan, 806-8501
    • GSK Investigational Site
  • Fukuoka, Japan, 807-8555
    • GSK Investigational Site
  • Fukuoka, Japan, 810-8563
    • GSK Investigational Site
  • Fukuoka, Japan, 815-8555
    • GSK Investigational Site
  • Gifu, Japan, 503-8502
    • GSK Investigational Site
  • Gunma, Japan, 377-0280
    • GSK Investigational Site
  • Hyōgo, Japan, 670-8540
    • GSK Investigational Site
  • Kanagawa, Japan, 247-8533
    • GSK Investigational Site
  • Kanagawa, Japan, 221-0855
    • GSK Investigational Site
  • Kochi, Japan, 781-8555
    • GSK Investigational Site
  • Nagano, Japan, 392-8510
    • GSK Investigational Site
  • Okayama, Japan, 701-1192
    • GSK Investigational Site
  • Osaka, Japan, 545-8586
    • GSK Investigational Site
  • Osaka, Japan, 530-0012
    • GSK Investigational Site
  • Shizuoka, Japan, 411-8777
    • GSK Investigational Site
• Netherlands
  • Dordrecht, Netherlands, 3318 AT
    • GSK Investigational Site
  • Groningen, Netherlands, 9713 GZ
    • GSK Investigational Site
• Poland
  • Chorzów, Poland, 41-500
    • GSK Investigational Site
  • Krakow, Poland, 30510
    • GSK Investigational Site
  • Lodz, Poland, 93-513
    • GSK Investigational Site
  • Lublin, Poland, 20-081
    • GSK Investigational Site
  • Lublin, Poland, 20-090
    • GSK Investigational Site
  • Nowy Sącz, Poland, 33-300
    • GSK Investigational Site
  • Poznan, Poland, 60-569
    • GSK Investigational Site
  • Warsaw, Poland, 02-781
    • GSK Investigational Site
• Russia
  • Moscow, Russia, 125284
    • GSK Investigational Site
  • Nizhny Novgorod, Russia, 603126
    • GSK Investigational Site
  • Novosibirsk, Russia, 630087
    • GSK Investigational Site
  • Saint Petersburg, Russia, 191024
    • GSK Investigational Site
  • Saint Petersburg, Russia, 197 089
    • GSK Investigational Site
  • Saratov, Russia, 410028
    • GSK Investigational Site
  • Ufa, Russia, 450083
    • GSK Investigational Site
• South Korea
  • Pusan, South Korea, 49241
    • GSK Investigational Site
  • Ulsan, South Korea, 44033
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Barcelona, Spain, 08916
    • GSK Investigational Site
  • Cáceres, Spain, 10003
    • GSK Investigational Site
  • Gijón, Spain, 33394
    • GSK Investigational Site
  • L'Hospitalet de Llobrega, Spain, 08908
    • GSK Investigational Site
  • Murcia, Spain, 30008
    • GSK Investigational Site
  • PamplonaNavarra, Spain, 31008
    • GSK Investigational Site
  • Salamanca, Spain, 37007
    • GSK Investigational Site
• United States
  • Arizona
    • Yuma, Arizona, United States, 85364
      • GSK Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80218
      • GSK Investigational Site
  • Kansas
    • Kansas City, Kansas, United States, 66205
      • GSK Investigational Site
  • Ohio
    • Fairfield, Ohio, United States, 45242
      • GSK Investigational Site
  • Texas
    • Tyler, Texas, United States, 75702
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)	Drug: Belantamab mafodotin; Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate; Drug: Bortezomib; Proteasome Inhibitor; Drug: Dexamethasone; Synthetic glucocorticoid with anti-tumor activity
Active Comparator: Daratumumab and Bortezomib plus Dexamethasone (Arm B)	Drug: Bortezomib; Proteasome Inhibitor; Drug: Dexamethasone; Synthetic glucocorticoid with anti-tumor activity; Drug: Daratumumab; Anti-cluster of differentiation 38 [CD-38] monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5 grams per deciliter {g/dL}]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200 milligrams per 24 hours {mg/24h}]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved serum free light chains (sFLC) levels [absolute increase >10mg/dL]; appearance of new lesion,>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in longest diameter of previous lesion >1 centimeter (cm) in short axis.	Up to approximately 41 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response Rate (CRR)	CRR is defined as percentage of participants with a confirmed complete response or better.	Up to 73 months
Overall Response Rate (ORR)	ORR is defined as percentage of participants with a confirmed partial response or better.	Up to 73 months
Clinical Benefit Rate (CBR)	CBR is defined as percentage of participants with a confirmed minimal response (MR) or better	Up to 73 months
Duration of Response (DoR)	DOR is defined as time from first documented evidence of partial response or better until first documented progression or death, whichever occurs first.	Up to 73 months
Time to Response (TTR)	TTR is defined as time from the date of randomization and the first documented evidence of response (PR or better) among participants who achieve partial response or better.	Up to 73 months
Time to Progression (TTP)	TTP is defined as time from the date of randomization until the earliest date of documented date of disease progression or death, whichever occurs first.	Up to 73 months
Overall Survival (OS)	OS is defined as time from the date of randomization until the date of death due to any cause.	Up to 73 months
Progression-free Survival on Subsequent Line of Therapy (PFS2)	Progression-free survival on subsequent line of therapy is defined as time from randomization 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.	Up to 73 months
Minimal Residual Disease (MRD) Negativity Rate	Minimal Residual Disease (MRD) negativity rate is defined as the percentage of participants who are MRD negative status by next generation sequencing (NGS).	Up to 73 months
Number of Participants With Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.	Up to 73 months
Number of Participants With Clinically Significant Changes in Hematology Parameters	Blood samples will be collected for the analysis of hematology parameters.	Up to 73 months
Number of Participants With Clinically Significant Changes in Clinical Chemistry	Blood samples will be collected for the analysis of clinical chemistry parameters.	Up to 73 months
Number of Participants With Clinically Significant Changes in Urine Dipstick	Urine samples will be collected for the urine dipstick analysis.	Up to 73 months
Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination		Up to 73 months
Plasma Concentrations of Belantamab Mafodotin (Total Antibody) at Indicated Time Points	Blood samples will be collected for PK analysis of belantamab mafodotin.	Up to 73 months
Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points	Blood samples will be collected for PK analysis of belantamab mafodotin.	Up to 73 months
Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points	Blood samples will be collected for PK analysis of belantamab mafodotin.	Up to 73 months
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin	Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be tested in screening assay, and positive samples will be further characterized for antibody titers.	Up to 73 months
Titers of ADAs Against Belantamab Mafodotin	Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be to be further tested in screening assay, and positive samples will be further to be characterized for antibody titers.	Up to 73 months
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)	The PRO-CTCAE is a patient-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 78 symptomatic toxicities drawn from the CTCAE.	Up to 73 months
Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by EuropeanOrganization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)	The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.	Up to 73 months
Change From Baseline in HRQoL as Measured by EORTC IL52	The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score represents a high/healthy level of functioning.	Up to 73 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

General Publications

• Mateos MV, Trudel S, Quach H, Robak P, Beksac M, Pour L, Hus M, Kim K, Zherebtsova V, Delimpasi S, Jelinek T, Ward C, Ho PJ, Vorobyev V, Pitombeira de Lacerda M, Aparecida-Martinez G, Spicka I, Radocha J, Cavo M, Cerchione C, Fu C, Suzuki K, Rogers R, Phillips-Jones A, Wang Z, Baig H, Wilkes J, Zhou XL, Lewis E, Eccersley L, Sule N, Paka P, Opalinska JB, Mukhopadhyay P, Hungria V, Dimopoulos MA. Modification of belantamab mafodotin dosing to balance efficacy and tolerability in the DREAMM-7 and DREAMM-8 trials. Blood Adv. 2025 Nov 25;9(22):5708-5719. doi: 10.1182/bloodadvances.2025016949.
• Hungria V, Robak P, Hus M, Zherebtsova V, Ward C, Ho PJ, Hajek R, Kim K, Grosicki S, Sia H, Bryant A, Pitombeira de Lacerda M, Martinez GA, Sureda Balari A, Sandhu I, Cerchione C, Ganly P, Dimopoulos MA, Fu C, Garg M, Abdallah AO, Gatt ME, Oriol Rocafiguera A, Cavo M, Rifkin R, Fujisaki T, Mielnik M, Ficek J, Mantero A, Pirooz N, Varghese S, Lee J, McKeown A, Rogers R, Baig H, Eccersley L, Roy-Ghanta S, Mukhopadhyay P, Nielsen J, Opalinska J, Mateos MV; DREAMM-7 study investigators. Belantamab mafodotin plus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): updated overall survival analysis from a global, randomised, open-label, phase 3 trial. Lancet Oncol. 2025 Aug;26(8):1067-1080. doi: 10.1016/S1470-2045(25)00330-4. Epub 2025 Jul 15.
• Hungria V, Hus M, Fu C, Zherebtsova V, Ward C, Ho PJ, Mikulski D, Muronova L, Cerchione C, Loubert A, Bunod L, M'Hari M, Pirooz N, Rogers R, Lin CP, Roy-Ghanta S, Opalinska JB, Purser M, McKeown A, McNamara S, Baig H, Eccersley L, Pompilus F, Mateos MV; DREAMM-7 trial study group. Patient-reported outcomes with belantamab mafodotin, bortezomib, and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): results from a phase 3, open-label, randomised controlled trial. Lancet Haematol. 2025 Aug;12(8):e599-e610. doi: 10.1016/S2352-3026(25)00163-2. Epub 2025 Jul 15.
• Hungria V, Robak P, Hus M, Zherebtsova V, Ward C, Ho PJ, Ribas de Almeida AC, Hajek R, Kim K, Grosicki S, Sia H, Bryant A, Pitombeira de Lacerda M, Aparecida Martinez G, Sureda Balari AM, Sandhu I, Cerchione C, Ganly P, Dimopoulos M, Fu C, Garg M, Abdallah AO, Oriol A, Gatt ME, Cavo M, Rifkin R, Fujisaki T, Mielnik M, Pirooz N, McKeown A, McNamara S, Zhou X, Nichols M, Lewis E, Rogers R, Baig H, Eccersley L, Roy-Ghanta S, Opalinska J, Mateos MV; DREAMM-7 Investigators. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2020
• Primary Completion (Actual): October 2, 2023
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Daratumumab; Dexamethasone; Bortezomib; Belantamab mafodotin; Relapsed/refractory multiple myeloma; Global Cohort
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Inorganic Chemicals; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Pyrazines; Bortezomib; Dexamethasone; daratumumab; belantamab mafodotin
• Other Study ID Numbers: 207503; 2023-510537-28-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.
• 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No