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

Last updated: March 11, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Not Recruiting

Phase

3

Condition

Multiple Myeloma

Cancer/tumors

Leukemia

Treatment

Pomalidomide

Belantamab mafodotin

Bortezomib

Clinical Study ID

NCT04484623
207499
2018-004354-21
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 InternationalMyeloma 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 alenalidomide-containing regimen and must have documented disease progression duringor after their most recent therapy. (Participants treated with lenalidomide ≥10 mgdaily for at least 2 consecutive cycles are eligible).

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

  1. Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or

  2. Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (≥5.0 g/liter [L]),or

  3. 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 transplantineligible. Participants with a history of ASCT are eligible for study participationprovided the following eligibility criteria are met: a. ASCT was >100 days prior tothe first dose of study medication. b. No active bacterial, viral, or fungalinfection(s) present

  • All prior treatment-related toxicities (defined by National Cancer Institute CommonTerminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be less thanor 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 contraceptiverequirements.

Exclusion

Exclusion Criteria:

  • Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy,organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skinchanges (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 studydrug; prior treatment with a monoclonal antibody drug within 30 days of receivingthe 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; participantexperienced progressive disease during treatment, or within 60 days of completingtreatment, with a bortezomib-containing regimen of 1.3 mg/meter square [m^2] twiceweekly).

  • Evidence of cardiovascular risk including any of the following;

  1. Evidence of current clinically significant untreated arrhythmias, includingclinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block.

  2. Recent history within (3 months of screening) of myocardial infarction, acutecoronary syndromes (including unstable angina), coronary angioplasty, orstenting or bypass grafting .

  3. Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system

  4. Uncontrolled hypertension.

  • Any major surgery within the last 4 weeks.

  • Previous or concurrent invasive malignancy other than multiple myeloma, except:

  1. The disease must be considered medically stable for at least 2 years; or

  2. The participant must not be receiving active therapy, other than hormonaltherapy for this disease.

  • Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction tobelantamab mafodotin or drugs chemically related to belantamab mafodotin, or any ofthe components of the study treatment.

  • Evidence of active mucosal or internal bleeding.

  • Cirrhosis or current unstable liver or biliary disease per investigator assessmentdefined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia,esophageal or gastric varices, persistent jaundice.

  • Active infection requiring treatment.

  • Known or active human immunodeficiency virus (HIV) infection, hepatitis B orhepatitis C will be excluded unless the protocol-defined criteria are met.

  • Presence of active renal conditions (such as infection, severe renal impairmentrequiring dialysis or any other condition that could affect participant's safety).

  • Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior torandomization or ≥Grade 3 peripheral neuropathy.

  • Active or history of venous and arterial thromboembolism within the past 3 months.

  • Contraindications to or unwilling to undergo protocol-required anti-thromboticprophylaxis.

  • Current corneal disease except for mild punctate keratopathy.

  • Any serious and/or unstable pre-existing medical, psychiatric disorder or otherconditions (including laboratory abnormalities) that could interfere withparticipant's safety, obtaining informed consent or compliance to the studyprocedures.

  • Pregnant or lactating female.

Study Design

Total Participants: 302
Treatment Group(s): 4
Primary Treatment: Pomalidomide
Phase: 3
Study Start date:
October 01, 2020
Estimated Completion Date:
October 25, 2029

Connect with a study center

  • GSK Investigational Site

    Canberra, Australian Capital Territory 2605
    Australia

    Site Not Available

  • GSK Investigational Site

    Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • GSK Investigational Site

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • GSK Investigational Site

    Gosford, New South Wales 2250
    Australia

    Site Not Available

  • GSK Investigational Site

    Gosford NSW, New South Wales 2250
    Australia

    Site Not Available

  • GSK Investigational Site

    Port Macquarie, New South Wales 2444
    Australia

    Site Not Available

  • GSK Investigational Site

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • GSK Investigational Site

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • GSK Investigational Site

    Benowa, Queensland 4217
    Australia

    Site Not Available

  • GSK Investigational Site

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • GSK Investigational Site

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • GSK Investigational Site

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • GSK Investigational Site

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • GSK Investigational Site

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • GSK Investigational Site

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • GSK Investigational Site

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • GSK Investigational Site

    Curitiba, 01308-050
    Brazil

    Site Not Available

  • GSK Investigational Site

    Joinville, 89201-260
    Brazil

    Site Not Available

  • GSK Investigational Site

    Porto Alegre, 90035-903
    Brazil

    Site Not Available

  • GSK Investigational Site

    Rio de Janeiro, 22793-080
    Brazil

    Site Not Available

  • GSK Investigational Site

    SAo Paulo, 04537-081
    Brazil

    Site Not Available

  • GSK Investigational Site

    São Paulo, 01509-900
    Brazil

    Site Not Available

  • GSK Investigational Site

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • GSK Investigational Site

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • GSK Investigational Site

    Montreal, H2X 0A9
    Canada

    Site Not Available

  • GSK Investigational Site

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • GSK Investigational Site

    Shenzhen, Guangdong 518029
    China

    Site Not Available

  • GSK Investigational Site

    Wuhan, Hubei 430022
    China

    Site Not Available

  • GSK Investigational Site

    Xuzhou, Jiangsu 221004
    China

    Site Not Available

  • GSK Investigational Site

    Beijing, 100191
    China

    Site Not Available

  • GSK Investigational Site

    Changchun, 130012
    China

    Site Not Available

  • GSK Investigational Site

    Changsha, 410013
    China

    Site Not Available

  • GSK Investigational Site

    Hangzhou, 310003
    China

    Site Not Available

  • GSK Investigational Site

    Jiangsu, 221004
    China

    Site Not Available

  • GSK Investigational Site

    Nanchang, 330006
    China

    Site Not Available

  • GSK Investigational Site

    Shenyang, 110004
    China

    Site Not Available

  • GSK Investigational Site

    Tianjin, 300020
    China

    Site Not Available

  • GSK Investigational Site

    Brno, 62500
    Czechia

    Site Not Available

  • GSK Investigational Site

    Hradec Kralove, 50333
    Czechia

    Site Not Available

  • GSK Investigational Site

    Praha 2, 12808
    Czechia

    Site Not Available

  • GSK Investigational Site

    Dijon cedex, 21079
    France

    Site Not Available

  • GSK Investigational Site

    Marseille, 13273
    France

    Site Not Available

  • GSK Investigational Site

    Marseille Cedex 9, 13273
    France

    Site Not Available

  • GSK Investigational Site

    Périgueux cedex, 24019
    France

    Site Not Available

  • GSK Investigational Site

    Toulouse cedex 9, 31059
    France

    Site Not Available

  • GSK Investigational Site

    Vandeouvre-les-Nancy, 54500
    France

    Site Not Available

  • GSK Investigational Site

    Vandoeuvre-Les-Nancy, 54511
    France

    Site Not Available

  • GSK Investigational Site

    Vanduvre-lEs-Nancy, 54511
    France

    Site Not Available

  • GSK Investigational Site

    Heidelberg, Baden-Wuerttemberg 69120
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • GSK Investigational Site

    Jena, Thueringen 07747
    Germany

    Site Not Available

  • GSK Investigational Site

    Berlin, 12351
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg, 20246
    Germany

    Site Not Available

  • GSK Investigational Site

    Mainz, 55131
    Germany

    Site Not Available

  • GSK Investigational Site

    Tuebingen, 72076
    Germany

    Site Not Available

  • GSK Investigational Site

    Wuerzburg, 97080
    Germany

    Site Not Available

  • GSK Investigational Site

    Athens, 10676
    Greece

    Site Not Available

  • GSK Investigational Site

    Ioannina, 45 500
    Greece

    Site Not Available

  • GSK Investigational Site

    Larisa, 41110
    Greece

    Site Not Available

  • GSK Investigational Site

    Rio/Patras, 26504
    Greece

    Site Not Available

  • GSK Investigational Site

    Thessaloniki, 57010
    Greece

    Site Not Available

  • GSK Investigational Site

    Ashdod, 7747629
    Israel

    Site Not Available

  • GSK Investigational Site

    Beer-Sheva, 84101
    Israel

    Site Not Available

  • GSK Investigational Site

    Haifa, 3109601
    Israel

    Site Not Available

  • GSK Investigational Site

    Jerusalem, 91031
    Israel

    Site Not Available

  • GSK Investigational Site

    Kfar Saba, 4428164
    Israel

    Site Not Available

  • GSK Investigational Site

    Nahariya, 2633737
    Israel

    Site Not Available

  • GSK Investigational Site

    Petach Tikva, 49100
    Israel

    Site Not Available

  • GSK Investigational Site

    Petach-Tikva, 4941492
    Israel

    Site Not Available

  • GSK Investigational Site

    Ramat Gan, 52621
    Israel

    Site Not Available

  • GSK Investigational Site

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • GSK Investigational Site

    San Giovanni Rotondo, Puglia 71013
    Italy

    Site Not Available

  • GSK Investigational Site

    Bologna, 40138
    Italy

    Site Not Available

  • GSK Investigational Site

    Milano, 20122
    Italy

    Site Not Available

  • GSK Investigational Site

    Pavia, 27100
    Italy

    Site Not Available

  • GSK Investigational Site

    Roma, 00161
    Italy

    Site Not Available

  • GSK Investigational Site

    Aichi, 467-8602
    Japan

    Site Not Available

  • GSK Investigational Site

    Chiba, 296-8602
    Japan

    Site Not Available

  • GSK Investigational Site

    Ehime, 790-8524
    Japan

    Site Not Available

  • GSK Investigational Site

    Fukuoka, 810-8563
    Japan

    Site Not Available

  • GSK Investigational Site

    Fukushima, 960-1295
    Japan

    Site Not Available

  • GSK Investigational Site

    Gunma, 377-0280
    Japan

    Site Not Available

  • GSK Investigational Site

    Hiroshima, 720-0001
    Japan

    Site Not Available

  • GSK Investigational Site

    Hokkaido, 060-8648
    Japan

    Site Not Available

  • GSK Investigational Site

    Iwate, 028-3695
    Japan

    Site Not Available

  • GSK Investigational Site

    Kumamoto, 860-0008
    Japan

    Site Not Available

  • GSK Investigational Site

    Kyoto, 602-8566
    Japan

    Site Not Available

  • GSK Investigational Site

    Okayama, 701-1192
    Japan

    Site Not Available

  • GSK Investigational Site

    Osaka, 565-0871
    Japan

    Site Not Available

  • GSK Investigational Site

    Saitama, 350-0495
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokushima, 770-8539
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokyo, 108-8639
    Japan

    Site Not Available

  • GSK Investigational Site

    Tottori, 683-8504
    Japan

    Site Not Available

  • GSK Investigational Site

    Yamagata, 990-9585
    Japan

    Site Not Available

  • GSK Investigational Site

    Busan, 49241
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Gyeonggi-do, 10408
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Hwasun, 58128
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Hwasun-gun, Jeollanam-do, 58128
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Incheon, 405-760
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Inchon, 21565
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Ulsan, 44033
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Auckland, 2025
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Christchurch, 8011
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Dunedin, 9016
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Grafton, 1023
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Grafton, Auckland, 1023
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Hamilton, 3204
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Takapuna Auckland, 622
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Tauranga, 3143
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • GSK Investigational Site

    Gdansk, 80-214
    Poland

    Site Not Available

  • GSK Investigational Site

    Krakow, 31-501
    Poland

    Site Not Available

  • GSK Investigational Site

    Lodz, 93-513
    Poland

    Site Not Available

  • GSK Investigational Site

    Lublin, 20-090
    Poland

    Site Not Available

  • GSK Investigational Site

    Wroclaw, 50-367
    Poland

    Site Not Available

  • GSK Investigational Site

    Kaluga, 248007
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Moscow, 125284
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Nizhniy Novgorod, 603126
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Novosibirsk, 630087
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Omsk, 644013
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Saint Petersburg, 197341
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Samara, 443099
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Sochi, 354057
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    St Petersburg, 191024
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    St'Petersburg, 191024
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    St-Petersburg, 194291
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    St. Petersburg, 197 089
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Tula, 300053
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Móstoles, Madrid 28933
    Spain

    Site Not Available

  • GSK Investigational Site

    Badalona, ?08036
    Spain

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08036
    Spain

    Site Not Available

  • GSK Investigational Site

    Gijon, 33204
    Spain

    Site Not Available

  • GSK Investigational Site

    Hospitalet de Llobregat (Barcelona), 08908
    Spain

    Site Not Available

  • GSK Investigational Site

    L'Hospitalet De Llobrega, 08908
    Spain

    Site Not Available

  • GSK Investigational Site

    MOstoles Madrid, 28933
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28027
    Spain

    Site Not Available

  • GSK Investigational Site

    Murcia, 30008
    Spain

    Site Not Available

  • GSK Investigational Site

    Palma de Mallorca, 07120
    Spain

    Site Not Available

  • GSK Investigational Site

    Pamplona, 31008
    Spain

    Site Not Available

  • GSK Investigational Site

    PamplonaNavarra, 31008
    Spain

    Site Not Available

  • GSK Investigational Site

    Pozuelo De AlarcOn Madr, 28223
    Spain

    Site Not Available

  • GSK Investigational Site

    Pozuelo De Alarcón/Madrid, 28223
    Spain

    Site Not Available

  • GSK Investigational Site

    Salamanca, 37007
    Spain

    Site Not Available

  • GSK Investigational Site

    Sevilla, 41013
    Spain

    Site Not Available

  • GSK Investigational Site

    Valencia, 46026
    Spain

    Site Not Available

  • GSK Investigational Site

    Ankara, 6560
    Turkey

    Site Not Available

  • GSK Investigational Site

    Istanbul, 34214
    Turkey

    Site Not Available

  • GSK Investigational Site

    Izmir, 35100
    Turkey

    Site Not Available

  • GSK Investigational Site

    Kocaeli, 41400
    Turkey

    Site Not Available

  • GSK Investigational Site

    Mersin, 33343
    Turkey

    Site Not Available

  • GSK Investigational Site

    Samsun, 55139
    Turkey

    Site Not Available

  • GSK Investigational Site

    Airdrie, Lanarkshire ML6 0JS
    United Kingdom

    Site Not Available

  • GSK Investigational Site

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

    Site Not Available

  • GSK Investigational Site

    Bournemouth, BH7 7DW
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    London, W12 0HS
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Plymouth, PL6 8D8
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Stoke on Trent, ST4 6QG
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Tucson, Arizona 85712
    United States

    Site Not Available

  • GSK Investigational Site

    Denver, Colorado 80218
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • GSK Investigational Site

    New Port Richey, Florida 34655
    United States

    Site Not Available

  • GSK Investigational Site

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • GSK Investigational Site

    Coeur d'Alene, Idaho 83814
    United States

    Site Not Available

  • GSK Investigational Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • GSK Investigational Site

    Kansas City, Missouri 64132
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • GSK Investigational Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • GSK Investigational Site

    Seattle, Washington 98109
    United States

    Site Not Available

  • GSK Investigational Site

    Spokane, Washington 99202
    United States

    Site Not Available

  • GSK Investigational Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.