Multiple Myeloma Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

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 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.

Exclusion Criteria:

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
The participant must not be receiving active therapy, other than hormonal therapy for this disease.
Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
Evidence of active mucosal or internal bleeding.
Cirrhosis or current unstable liver or biliary disease per investigator assessment defined 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 or hepatitis C will be excluded unless the protocol-defined criteria are met.
Presence of active renal conditions (such as infection, severe renal impairment requiring dialysis or any other condition that could affect participant's safety).
Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior to randomization 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-thrombotic prophylaxis.
Current corneal disease except for mild punctate keratopathy.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
Pregnant or lactating female.

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

357

Study ID:

NCT04484623

Recruitment Status:

Recruiting

Sponsor:

GlaxoSmithKline

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There are 128 Locations for this study

See Locations Near You

GSK Investigational Site
Tucson Arizona, 85712, United States
GSK Investigational Site
Fort Myers Florida, 33901, United States
GSK Investigational Site
Boston Massachusetts, 02215, United States
GSK Investigational Site
Kansas City Missouri, 64132, United States
GSK Investigational Site
Nashville Tennessee, 37203, United States
GSK Investigational Site
Canberra Australian Capital Territory, 2605, Australia
GSK Investigational Site
Darlinghurst New South Wales, 2010, Australia
GSK Investigational Site
Gosford New South Wales, 2250, Australia
GSK Investigational Site
Port Macquarie New South Wales, 2444, Australia
GSK Investigational Site
Benowa Queensland, 4217, Australia
GSK Investigational Site
South Brisbane Queensland, 4101, Australia
GSK Investigational Site
Adelaide South Australia, 5000, Australia
GSK Investigational Site
Fitzroy Victoria, 3065, Australia
GSK Investigational Site
Heidelberg Victoria, 3084, Australia
GSK Investigational Site
Malvern Victoria, 3144, Australia
GSK Investigational Site
Nedlands Western Australia, 6009, Australia
GSK Investigational Site
Joinville Santa Catarina, 89201, Brazil
GSK Investigational Site
Curitiba , 80530, Brazil
GSK Investigational Site
São Paulo , 04537, Brazil
GSK Investigational Site
Guangzhou Guangdong, 51006, China More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Zhongjun Xia
Principal Investigator
GSK Investigational Site
Shenzhen Guangdong, 51802, China More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Xin Du
Principal Investigator
GSK Investigational Site
Wuhan Hubei, 43002, China More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Chunyan Sun
Principal Investigator
GSK Investigational Site
Changsha Hunan, 41001, China More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Xin Li
Principal Investigator
GSK Investigational Site
Xuzhou Jiangsu, 22100, China More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Zhiling Yan
Principal Investigator
GSK Investigational Site
Nanchang Jiangxi, 33000, China More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Fei Li
Principal Investigator
GSK Investigational Site
Changchun Jilin, 13001, China More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Sujun Gao
Principal Investigator
GSK Investigational Site
Shenyang Liaoning, 11000, China More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Wei Yang
Principal Investigator
GSK Investigational Site
Hangzhou Zhejiang, 31000, China More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Zhen Cai
Principal Investigator
GSK Investigational Site
Beijing , 10019, China More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Hongmei Jing
Principal Investigator
GSK Investigational Site
Beijing , , China More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Zhongxia Huang
Principal Investigator
GSK Investigational Site
Tianjin , 30002, China More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Weiwei Sui
Principal Investigator
GSK Investigational Site
Brno , 625 0, Czechia
GSK Investigational Site
Hradec Kralove , 500 0, Czechia
GSK Investigational Site
Praha 2 , 128 0, Czechia
GSK Investigational Site
Marseille Cedex 9 , 13273, France
GSK Investigational Site
Toulouse cedex 9 , 31059, France
GSK Investigational Site
Vandeouvre-les-Nancy , 54500, France
GSK Investigational Site
Tuebingen Baden-Wuerttemberg, 72076, Germany
GSK Investigational Site
Wuerzburg Bayern, 97080, Germany
GSK Investigational Site
Mainz Rheinland-Pfalz, 55101, Germany
GSK Investigational Site
Jena Thueringen, 07747, Germany
GSK Investigational Site
Athens , 10676, Greece
GSK Investigational Site
Athens , 115 2, Greece
GSK Investigational Site
Athens , 11525, Greece
GSK Investigational Site
Ioannina , 45 50, Greece
GSK Investigational Site
Thessaloniki , 57010, Greece
GSK Investigational Site
Ashdod , 77476, Israel
GSK Investigational Site
Haifa , 31096, Israel
GSK Investigational Site
Jerusalem , 91031, Israel
GSK Investigational Site
Kfar Saba , 44281, Israel
GSK Investigational Site
Nahariya , 22100, Israel
GSK Investigational Site
Petach Tikva , 49100, Israel
GSK Investigational Site
Tel Aviv , 64239, Israel
GSK Investigational Site
Bologna Emilia-Romagna, 40138, Italy
GSK Investigational Site
Roma Lazio, 00161, Italy
GSK Investigational Site
Pavia Lombardia, 27100, Italy
GSK Investigational Site
Milano , 20122, Italy
GSK Investigational Site
Aichi , 467-8, Japan
GSK Investigational Site
Chiba , 296-8, Japan
GSK Investigational Site
Ehime , 790-8, Japan
GSK Investigational Site
Fukuoka , 810-8, Japan
GSK Investigational Site
Fukushima , 960-1, Japan
GSK Investigational Site
Gunma , 371-8, Japan
GSK Investigational Site
Gunma , 377-0, Japan
GSK Investigational Site
Hiroshima , 720-0, Japan
GSK Investigational Site
Hokkaido , 060-8, Japan
GSK Investigational Site
Iwate , 028-3, Japan
GSK Investigational Site
Kumamoto , 860-0, Japan
GSK Investigational Site
Kyoto , 602-8, Japan
GSK Investigational Site
Okayama , 701-1, Japan
GSK Investigational Site
Osaka , 565-0, Japan
GSK Investigational Site
Saitama , 350-0, Japan
GSK Investigational Site
Tokushima , 770-8, Japan
GSK Investigational Site
Tokyo , 108-8, Japan
GSK Investigational Site
Tokyo , 135-8, Japan
GSK Investigational Site
Tottori , 683-8, Japan
GSK Investigational Site
Yamagata , 990-9, Japan
GSK Investigational Site
Gyeonggi-do , 10408, Korea, Republic of
GSK Investigational Site
Hwasun-gun, Jeollanam-do , 58128, Korea, Republic of
GSK Investigational Site
Incheon , 405-7, Korea, Republic of
GSK Investigational Site
Seoul , 03722, Korea, Republic of
GSK Investigational Site
Seoul , 06351, Korea, Republic of
GSK Investigational Site
Seoul , 06591, Korea, Republic of
GSK Investigational Site
Seoul , 110-7, Korea, Republic of
GSK Investigational Site
Ulsan , 44033, Korea, Republic of
GSK Investigational Site
Auckland , 2025, New Zealand
GSK Investigational Site
Auckland , 622, New Zealand
GSK Investigational Site
Dunedin , 9001, New Zealand
GSK Investigational Site
Grafton, Auckland , 1023, New Zealand
GSK Investigational Site
Hamilton , 2001, New Zealand
GSK Investigational Site
Tauranga , 3143, New Zealand
GSK Investigational Site
Bydgoszcz , 85-16, Poland
GSK Investigational Site
Gdansk , 80-21, Poland
GSK Investigational Site
Krakow , 31-50, Poland
GSK Investigational Site
Lodz , 93-51, Poland
GSK Investigational Site
Wroclaw , 50-36, Poland
GSK Investigational Site
Moscow , 12528, Russian Federation
GSK Investigational Site
Novosibirsk , 63008, Russian Federation
GSK Investigational Site
Saint Petersburg , 19734, Russian Federation
GSK Investigational Site
Samara , 44309, Russian Federation
GSK Investigational Site
Sochi , 35405, Russian Federation
GSK Investigational Site
St'Petersburg , 19102, Russian Federation
GSK Investigational Site
St. Petersburg , 197 0, Russian Federation
GSK Investigational Site
Móstoles Madrid, 28933, Spain
GSK Investigational Site
Madrid Navarra, 28027, Spain
GSK Investigational Site
Badalona , ?0803, Spain
GSK Investigational Site
Barcelona , 08908, Spain
GSK Investigational Site
Barcelona , 8035, Spain
GSK Investigational Site
Gijon , 33204, Spain
GSK Investigational Site
Madrid , 28006, Spain
GSK Investigational Site
Murcia , 30008, Spain
GSK Investigational Site
Palma de Mallorca , 07010, Spain
GSK Investigational Site
Pamplona , 31008, Spain
GSK Investigational Site
Pozuelo De Alarcón/Madrid , 28223, Spain
GSK Investigational Site
Salamanca , 37007, Spain
GSK Investigational Site
Sevilla , 41013, Spain
GSK Investigational Site
Valencia , 46026, Spain
GSK Investigational Site
Ankara , 06100, Turkey
GSK Investigational Site
Ankara , 06560, Turkey
GSK Investigational Site
Ankara , 6110, Turkey
GSK Investigational Site
Izmir , 35100, Turkey
GSK Investigational Site
Izmir , 35340, Turkey
GSK Investigational Site
Kocaeli , 41400, Turkey
GSK Investigational Site
Mersin , 33343, Turkey
GSK Investigational Site
Samsun , 55139, Turkey
GSK Investigational Site
Southampton Hampshire, SO16 , United Kingdom
GSK Investigational Site
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom
GSK Investigational Site
Sutton Surrey, SM2 5, United Kingdom
GSK Investigational Site
London , W12 0, United Kingdom
GSK Investigational Site
Plymouth , PL6 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

357

Study ID:

NCT04484623

Recruitment Status:

Recruiting

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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