Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

NCT04484623 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2074992018-004354-21
• Study Type: interventional
• Target: 302
• Locations: 18 countries
• Sites: 122

Brief Summary

This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).

Conditions

Multiple Myeloma

Keywords

Global Cohort; Belantamab Mafodotin; Relapsed/Refractory Multiple Myeloma; Pomalidomide; Dexamethasone; Bortezomib

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 is defined as 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 174 weeks

Secondary Outcomes (28)

• Overall Survival (OS)

  Up to approximately 473 weeks

• Duration of Response (DoR)

  Up to approximately 473 weeks

• Minimal Residual Disease (MRD) Negativity Rate

  Up to approximately 473 weeks

• Overall Response Rate (ORR)

  Up to approximately 473 weeks

• Complete Response Rate (CRR)

  Up to approximately 473 weeks

Study Arms (2)

Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone

EXPERIMENTAL

Drug: Belantamab mafodotin; Drug: Pomalidomide; Drug: Dexamethasone

Arm B: Bortezomib plus Pomalidomide and Dexamethasone

ACTIVE COMPARATOR

Drug: Pomalidomide; Drug: Dexamethasone; Drug: Bortezomib

Interventions

Belantamab mafodotin DRUG

Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.

Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone

Pomalidomide DRUG

Immunomodulatory drug (IMiD) will be administered.

Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone; Arm B: Bortezomib plus Pomalidomide and Dexamethasone

Dexamethasone DRUG

Synthetic glucocorticoid with anti-tumor activity will be administered.

Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone; Arm B: Bortezomib plus Pomalidomide and Dexamethasone

Bortezomib DRUG

Proteasome Inhibitor will be administered.

Arm B: Bortezomib plus Pomalidomide and Dexamethasone

Eligibility Criteria

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

You may qualify if:

• Capable of giving signed informed consent.
• Male or female, 18 years or older.
• Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy. (Participants treated with lenalidomide ≥10 mg daily for at least 2 consecutive cycles are eligible).
• Must have at least 1 aspect of measurable disease defined as one of the following;
• Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or
• Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (≥5.0 g/liter \[L\]), or
• Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (less than \[\<\]0.26 or greater than \[\>\]1.65) only if participant has no measurable urine or serum M spike.
• Have undergone autologous stem cell transplant (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was \>100 days prior to the first dose of study medication. b. No active bacterial, viral, or fungal infection(s) present
• All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 5.0) must be less than or equal to (≤)Grade 1 at the time of enrolment, except for alopecia.
• Adequate organ system functions as mentioned in the protocol.
• Male and female participants agree to abide by protocol-defined contraceptive requirements.

You may not qualify if:

• Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening.
• Prior allogeneic SCT.
• Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
• Plasmapheresis within 7 days prior to the first dose of study drug.
• Received prior treatment with or intolerant to pomalidomide.
• Received prior Beta cell maturation antigen (BCMA) targeted therapy.
• Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/meter square \[m\^2\] twice weekly).
• Evidence of cardiovascular risk including any of the following;
• Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block.
• Recent history within (3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting .
• Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
• Uncontrolled hypertension.
• Any major surgery within the last 4 weeks.
• Previous or concurrent invasive malignancy other than multiple myeloma, except:
• The disease must be considered medically stable for at least 2 years; or

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (122)

GSK Investigational Site

Tucson, Arizona, 85712, United States

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GSK Investigational Site

Fort Myers, Florida, 33901, United States

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GSK Investigational Site

Boston, Massachusetts, 02215, United States

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GSK Investigational Site

Kansas City, Missouri, 64132, United States

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Nashville, Tennessee, 37203, United States

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GSK Investigational Site

Garran, Australian Capital Territory, 2605, Australia

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GSK Investigational Site

Darlinghurst, New South Wales, 2010, Australia

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GSK Investigational Site

Gosford NSW, New South Wales, 2250, Australia

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GSK Investigational Site

Port Macquarie, New South Wales, 2444, Australia

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GSK Investigational Site

Benowa, Queensland, 4217, Australia

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GSK Investigational Site

South Brisbane, Queensland, 4101, Australia

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GSK Investigational Site

Adelaide, South Australia, 5000, Australia

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GSK Investigational Site

Fitzroy, Victoria, 3065, Australia

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GSK Investigational Site

Heidelberg, Victoria, 3084, Australia

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GSK Investigational Site

Malvern, Victoria, 3144, Australia

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GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

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GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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GSK Investigational Site

Curitiba, 01308-050, Brazil

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GSK Investigational Site

Joinville, 89201-260, Brazil

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GSK Investigational Site

São Paulo, 04537-081, Brazil

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GSK Investigational Site

Beijing, 100191, China

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GSK Investigational Site

Beijing, China

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GSK Investigational Site

Changchun, 130012, China

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GSK Investigational Site

Changsha, 410013, China

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GSK Investigational Site

Guangzhou, 510060, China

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GSK Investigational Site

Hangzhou, 310003, China

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GSK Investigational Site

Jiangsu, 221004, China

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GSK Investigational Site

Nanchang, 330006, China

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GSK Investigational Site

Shenyang, 110004, China

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GSK Investigational Site

Shenzhen, 518029, China

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GSK Investigational Site

Tianjin, 300020, China

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GSK Investigational Site

Wuhan, 430022, China

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GSK Investigational Site

Brno, 62500, Czechia

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GSK Investigational Site

Hradec Králové, 50333, Czechia

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Prague, 12808, Czechia

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GSK Investigational Site

Marseille, 13273, France

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GSK Investigational Site

Toulouse, 31059, France

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GSK Investigational Site

Vanduvre-lEs-Nancy, 54511, France

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GSK Investigational Site

Mainz, 55131, Germany

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Tübingen, 72076, Germany

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GSK Investigational Site

Würzburg, 97080, Germany

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GSK Investigational Site

Athens, 10676, Greece

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GSK Investigational Site

Athens, 115 25, Greece

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GSK Investigational Site

Athens, 115 28, Greece

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GSK Investigational Site

Ioannina, 45 500, Greece

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GSK Investigational Site

Thessaloniki, 57010, Greece

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GSK Investigational Site

Haifa, 3109601, Israel

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Jerusalem, 91031, Israel

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GSK Investigational Site

Kfar Saba, 4428164, Israel

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GSK Investigational Site

Nahariya, 2633737, Israel

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Petah Tikva, 4941492, Israel

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Tel Aviv, 6423906, Israel

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Bologna, 40138, Italy

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GSK Investigational Site

Milan, 20122, Italy

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GSK Investigational Site

Pavia, 27100, Italy

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GSK Investigational Site

Roma, 00161, Italy

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GSK Investigational Site

Aichi, 467-8602, Japan

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GSK Investigational Site

Chiba, 277-8567, Japan

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GSK Investigational Site

Chiba, 296-8602, Japan

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GSK Investigational Site

Ehime, 790-8524, Japan

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GSK Investigational Site

Fukushima, 960-1295, Japan

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GSK Investigational Site

Gunma, 371-8511, Japan

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GSK Investigational Site

Gunma, 377-0280, Japan

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GSK Investigational Site

Hokkaido, 060-8648, Japan

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GSK Investigational Site

Numakunai, 028-3695, Japan

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GSK Investigational Site

Okayama, 701-1192, Japan

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GSK Investigational Site

Osaka, 565-0871, Japan

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GSK Investigational Site

Tottori, 683-8504, Japan

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GSK Investigational Site

Yamagata, 990-9585, Japan

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GSK Investigational Site

Auckland, 1023, New Zealand

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Auckland, 2025, New Zealand

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Dunedin, 9016, New Zealand

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Hamilton, 3204, New Zealand

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Takapuna Auckland, 622, New Zealand

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Tauranga, 3143, New Zealand

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Bydgoszcz, 85-168, Poland

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Gdansk, 80-214, Poland

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Krakow, 31-501, Poland

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GSK Investigational Site

Lodz, 93-513, Poland

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Wroclaw, 50-367, Poland

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GSK Investigational Site

Moscow, 125101, Russia

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GSK Investigational Site

Moscow, 125284, Russia

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GSK Investigational Site

Novosibirsk, 630087, Russia

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GSK Investigational Site

Saint Petersburg, 191024, Russia

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GSK Investigational Site

Saint Petersburg, 194291, Russia

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GSK Investigational Site

Saint Petersburg, 197341, Russia

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GSK Investigational Site

Samara, 443099, Russia

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GSK Investigational Site

Sochi, 354057, Russia

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GSK Investigational Site

Gyeonggi-do, 10408, South Korea

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GSK Investigational Site

Hwasun, 58128, South Korea

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GSK Investigational Site

Inchon, 21565, South Korea

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GSK Investigational Site

Seoul, 03080, South Korea

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GSK Investigational Site

Seoul, 03722, South Korea

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GSK Investigational Site

Seoul, 06351, South Korea

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GSK Investigational Site

Seoul, 06591, South Korea

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GSK Investigational Site

Barcelona, 08036, Spain

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GSK Investigational Site

Barcelona, 8035, Spain

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GSK Investigational Site

Gijón, 33204, Spain

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GSK Investigational Site

L'Hospitalet de Llobrega, 08908, Spain

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GSK Investigational Site

Madrid, 28006, Spain

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GSK Investigational Site

Madrid, 28027, Spain

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GSK Investigational Site

MOstoles Madrid, 28933, Spain

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GSK Investigational Site

Murcia, 30008, Spain

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GSK Investigational Site

Palma de Mallorca, 07120, Spain

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GSK Investigational Site

PamplonaNavarra, 31008, Spain

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GSK Investigational Site

Pozuelo de AlarcOn Madr, 28223, Spain

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Salamanca, 37007, Spain

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Seville, 41013, Spain

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GSK Investigational Site

Valencia, 46026, Spain

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GSK Investigational Site

Ankara, 06100, Turkey (Türkiye)

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GSK Investigational Site

Ankara, 6340, Turkey (Türkiye)

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GSK Investigational Site

Ankara, 6560, Turkey (Türkiye)

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GSK Investigational Site

Izmir, 35100, Turkey (Türkiye)

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GSK Investigational Site

Izmir, 35330, Turkey (Türkiye)

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GSK Investigational Site

Kocaeli, 41400, Turkey (Türkiye)

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GSK Investigational Site

Mersin, 33343, Turkey (Türkiye)

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GSK Investigational Site

Samsun, 55139, Turkey (Türkiye)

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GSK Investigational Site

London, W12 0HS, United Kingdom

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GSK Investigational Site

Plymouth, PL6 8D8, United Kingdom

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GSK Investigational Site

Southampton, SO16 6YD, United Kingdom

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GSK Investigational Site

Stoke-on-Trent, ST4 6QG, United Kingdom

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GSK Investigational Site

Sutton, SM2 5PT, United Kingdom

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Related Publications (4)

• Dimopoulos MA, Beksac M, Pour L, Delimpasi S, Vorobyev V, Quach H, Spicka I, Radocha J, Robak P, Kim K, Cavo M, Suzuki K, Wilkes J, McNamara S, Phillips-Jones A, Morris K, Pompilus F, Purser M, Sule N, Kremer B, Loubert A, Bunod L, M'Hari M, Zhou XL, Fulci G, Mateos MV, Trudel S; DREAMM-8 investigators. Patient-reported outcomes with belantamab mafodotin, pomalidomide, and dexamethasone versus bortezomib, pomalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-8): a phase 3, open-label, randomised controlled trial. Lancet Haematol. 2025 Nov;12(11):e876-e886. doi: 10.1016/S2352-3026(25)00256-X.

  PMID: 41193117 DERIVED

• Hanafin P, Ho YL, Papathanasiou T, Fulci G, Sule N, Kremer BE, Ferron-Brady G. Belantamab Mafodotin with Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: A Comprehensive Exposure-Response Analysis of the DREAMM-8 Study. Target Oncol. 2025 Sep;20(5):833-845. doi: 10.1007/s11523-025-01174-0. Epub 2025 Sep 16.

  PMID: 40958065 DERIVED

• 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

• Dimopoulos MA, Beksac M, Pour L, Delimpasi S, Vorobyev V, Quach H, Spicka I, Radocha J, Robak P, Kim K, Cavo M, Suzuki K, Morris K, Pompilus F, Phillips-Jones A, Zhou XL, Fulci G, Sule N, Kremer BE, Opalinska J, Mateos MV, Trudel S; DREAMM-8 Investigators. Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):408-421. doi: 10.1056/NEJMoa2403407. Epub 2024 Jun 2.

  PMID: 38828951 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotin; pomalidomide; Dexamethasone; Bortezomib

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)

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

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: July 21, 2020
• First Posted: July 23, 2020
• Study Start: October 1, 2020
• Primary Completion: January 29, 2024
• Study Completion (Estimated): June 25, 2029
• Last Updated: June 12, 2026
• Results First Posted: March 18, 2025

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5); RU (8); TU (8); CN (12); ES (14); FR (3); US (5); DE (3); IL (6); NZ (6); AU (11); CZ (3); PL (5); KR (7); GR (5); IT (4); JP (13); BR (4)