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

NCT04246047 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2075032023-510537-28-00
• Study Type: interventional
• Target: 494
• Locations: 13 countries
• Sites: 69

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.

Conditions

Multiple Myeloma

Keywords

Global Cohort; Belantamab mafodotin; Relapsed/refractory multiple myeloma; Daratumumab; Bortezomib; Dexamethasone; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Complete Response Rate (CRR)

  Up to 73 months

• Overall Response Rate (ORR)

  Up to 73 months

• Clinical Benefit Rate (CBR)

  Up to 73 months

• Duration of Response (DoR)

  Up to 73 months

• Time to Response (TTR)

  Up to 73 months

Study Arms (2)

Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)

EXPERIMENTAL

Drug: Belantamab mafodotin; Drug: Bortezomib; Drug: Dexamethasone

Daratumumab and Bortezomib plus Dexamethasone (Arm B)

ACTIVE COMPARATOR

Drug: Daratumumab; Drug: Bortezomib; Drug: Dexamethasone

Interventions

Belantamab mafodotin DRUG

Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate

Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)

Daratumumab DRUG

Anti-cluster of differentiation 38 \[CD-38\] monoclonal antibody

Daratumumab and Bortezomib plus Dexamethasone (Arm B)

Bortezomib DRUG

Proteasome Inhibitor

Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A); Daratumumab and Bortezomib plus Dexamethasone (Arm B)

Dexamethasone DRUG

Synthetic glucocorticoid with anti-tumor activity

Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A); Daratumumab and Bortezomib plus Dexamethasone (Arm B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (69)

GSK Investigational Site

Yuma, Arizona, 85364, United States

Location

GSK Investigational Site

Denver, Colorado, 80218, United States

Location

GSK Investigational Site

Kansas City, Kansas, 66205, United States

Location

GSK Investigational Site

Fairfield, Ohio, 45242, United States

Location

GSK Investigational Site

Tyler, Texas, 75702, United States

Location

GSK Investigational Site

Liverpool, New South Wales, 2170, Australia

Location

GSK Investigational Site

Wollongong, New South Wales, 2500, Australia

Location

GSK Investigational Site

Benowa, Queensland, 4217, Australia

Location

GSK Investigational Site

Brussels, 1090, Belgium

Location

GSK Investigational Site

Brussels, 1200, Belgium

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GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Roeselare, 8800, Belgium

Location

GSK Investigational Site

Beijing, 100191, China

Location

GSK Investigational Site

Jinan, 250012, China

Location

GSK Investigational Site

Shenyang, 110001, China

Location

GSK Investigational Site

Alexandroupoli, 68 100, Greece

Location

GSK Investigational Site

Athens, 11528, Greece

Location

GSK Investigational Site

Thessaloniki, 54007, Greece

Location

GSK Investigational Site

Tel Aviv, 64239, Israel

Location

GSK Investigational Site

Bergamo, 24127, Italy

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GSK Investigational Site

Meldola FC, 47014, Italy

Location

GSK Investigational Site

Milan, 20133, Italy

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GSK Investigational Site

Siena, 53100, Italy

Location

GSK Investigational Site

Aichi, 441-8570, Japan

Location

GSK Investigational Site

Aichi, 467-8602, Japan

Location

GSK Investigational Site

Aomori, 030-8553, Japan

Location

GSK Investigational Site

Ehime, 790-8524, Japan

Location

GSK Investigational Site

Fukuoka, 806-8501, Japan

Location

GSK Investigational Site

Fukuoka, 807-8555, Japan

Location

GSK Investigational Site

Fukuoka, 810-8563, Japan

Location

GSK Investigational Site

Fukuoka, 815-8555, Japan

Location

GSK Investigational Site

Gifu, 503-8502, Japan

Location

GSK Investigational Site

Gunma, 377-0280, Japan

Location

GSK Investigational Site

Hyōgo, 670-8540, Japan

Location

GSK Investigational Site

Kanagawa, 221-0855, Japan

Location

GSK Investigational Site

Kanagawa, 247-8533, Japan

Location

GSK Investigational Site

Kochi, 781-8555, Japan

Location

GSK Investigational Site

Nagano, 392-8510, Japan

Location

GSK Investigational Site

Okayama, 701-1192, Japan

Location

GSK Investigational Site

Osaka, 530-0012, Japan

Location

GSK Investigational Site

Osaka, 545-8586, Japan

Location

GSK Investigational Site

Shizuoka, 411-8777, Japan

Location

GSK Investigational Site

Dordrecht, 3318 AT, Netherlands

Location

GSK Investigational Site

Groningen, 9713 GZ, Netherlands

Location

GSK Investigational Site

Chorzów, 41-500, Poland

Location

GSK Investigational Site

Krakow, 30510, Poland

Location

GSK Investigational Site

Lodz, 93-513, Poland

Location

GSK Investigational Site

Lublin, 20-081, Poland

Location

GSK Investigational Site

Lublin, 20-090, Poland

Location

GSK Investigational Site

Nowy Sącz, 33-300, Poland

Location

GSK Investigational Site

Poznan, 60-569, Poland

Location

GSK Investigational Site

Warsaw, 02-781, Poland

Location

GSK Investigational Site

Moscow, 125284, Russia

Location

GSK Investigational Site

Nizhny Novgorod, 603126, Russia

Location

GSK Investigational Site

Novosibirsk, 630087, Russia

Location

GSK Investigational Site

Saint Petersburg, 191024, Russia

Location

GSK Investigational Site

Saint Petersburg, 197 089, Russia

Location

GSK Investigational Site

Saratov, 410028, Russia

Location

GSK Investigational Site

Ufa, 450083, Russia

Location

GSK Investigational Site

Pusan, 49241, South Korea

Location

GSK Investigational Site

Ulsan, 44033, South Korea

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Barcelona, 08916, Spain

Location

GSK Investigational Site

Cáceres, 10003, Spain

Location

GSK Investigational Site

Gijón, 33394, Spain

Location

GSK Investigational Site

L'Hospitalet de Llobrega, 08908, Spain

Location

GSK Investigational Site

Murcia, 30008, Spain

Location

GSK Investigational Site

PamplonaNavarra, 31008, Spain

Location

GSK Investigational Site

Salamanca, 37007, Spain

Location

Related Publications (4)

• 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.

  PMID: 40763276 DERIVED

• 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.

  PMID: 40680754 DERIVED

• 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.

  PMID: 40680752 DERIVED

• 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.

  PMID: 38828933 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotin; daratumumab; Bortezomib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: May 7, 2020
• Primary Completion: October 2, 2023
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 23, 2026
• Results First Posted: October 24, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8); CN (3); JP (19); PL (8); RU (7); AU (3); BE (4); IL (1); IT (4); GR (3); KR (2); US (5); NL (2)