Multiple Myeloma Clinical Trial
Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.
Capable of giving signed informed consent.
Participants must be 18 or older, at the time of signing the informed consent. In Republic of Korea, participants must be over 19 years of age inclusive, at the time of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Histologically or cytologically confirmed diagnosis of Multiple myeloma (MM) as defined according to IMWG, and : Has undergone autologous stem cell transplant (SCT), or is considered transplant ineligible; Has received at least 2 prior lines of anti-myeloma treatments, including at least 2 consecutive cycles of both lenalidomide and a proteasome inhibitor (given separately or in combination), and must have documented disease progression on, or within 60 days of, completion of the last treatment or must be non-responsive while on last treatment, where non-responsive is defined as not achieving at least Minimal Response (MR) after 2 complete treatment cycles. In such cases lack of achieving of at least MR must be determined no earlier than at least 4 weeks after the last treatment.
Has measurable disease with at least one of the following: Serum M-protein >=0.5 gram per deciliter (g/dL) (>=5 gram per Liter); Urine M-protein >=200 mg/24 hours; Serum free light chain (FLC) assay: Involved FLC level >=10 milligram per deciliter (mg/dL) (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
Participants with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met: Transplant was >100 days prior to initiating study treatment; No active infection(s).
Adequate organ system functions as defined: Absolute neutrophil count (ANC) >=1.0*10^9/L; Hemoglobin >= 8.0 g/dL; Platelets >= 50x10^9/L; Total bilirubin <=1.5* Upper limit of normal (ULN) (isolated bilirubin >1.5*ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent); ALT <=2.5*ULN; Estimated glomerular filtration rate (eGFR)>=30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2); Spot urine (albumin/creatinine ratios) <=500 milligram per gram (mg/g) (56 milligram per millimoles [mg/mmol]).
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following during the intervention period and until 6 months after the last dose of study intervention to allow for clearance of any altered sperm: Refrain from donating sperm PLUS, either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below depending on whether they are randomised to Arm 1 (belantamab mafodotin) or Arm 2 (pom/dex), even if they have undergone a successful vasectomy: Agree to use a male condom throughout study treatment including the 6 month follow-up period even if they have undergone a successful vasectomy and a female partner to use an additional highly effective contraceptive method with a failure rate of <1 percent per year when having sexual intercourse with a pregnant woman or of childbearing potential who is not currently pregnant. Four weeks for male participants on Treatment Arm 2 (pomdex).
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and agrees to abide by the following: Arm 1 (belantamab mafodotin): Use a contraceptive method that is highly effective (with a failure rate of <1 percent per year) which includes abstinence, preferably with low user dependency during the intervention period and for 4 months after last dose of study treatment. Arm 2 (pomdex): Due to pomalidomide being a thalidomide analogue risk embryofetal toxicity prescribed under pregnancy preventioncontrolled distribution program, WOCBP participants will be eligible if they commit either abstain continuously from heterosexual sexual intercourse or use two methods reliable birth control (one method that is highly effective), beginning weeks prior initiating treatment pomalidomide, therapy, interruptions continuing at least following discontinuation Two negative tests must obtained therapy. The first test should performed within 10-14 days second 24 hours prescribing And agrees not donate eggs (ova, oocytes) purpose reproduction this period. investigator confirm effectiveness contraceptive method(s) ahead intervention.
All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 5.0, 2017) must be <=Grade 1 at the time of enrollment, except for alopecia and Grade 2 peripheral neuropathy.
Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes); active plasma cell leukemia at the time of screening.
Systemic anti-myeloma therapy or use of an investigational drug within <14 days or 5 half-lives, whichever is shorter, before the first dose of study intervention.
Prior treatment with an anti-MM monoclonal antibody within 30 days prior to receiving the first dose of study intervention.
Prior B cell maturation antigen (BCMA)-targeted therapy or prior pomalidomide treatment.
Plasmapheresis within 7 days prior to the first dose of study intervention.
Prior allogeneic stem cell transplant. (Participants who have undergone syngeneic transplant will be allowed only if no history of, or currently active, Graft-Versus-Host Disease [GvHD]).
Any major surgery within the last 4 weeks.
Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil criteria as described in inclusion criteria.
Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.
History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
Evidence of active mucosal or internal bleeding.
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. (Stable chronic liver disease [including Gilbert's syndrome or asymptomatic gallstones] or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria)
Participants with previous or concurrent malignancies other than multiple myeloma are excluded, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. (Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction).
Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant uncontrolled arrhythmias including clinically significant electrocardiogram (ECG) abnormalities including 2nd degree (Mobitz Type II) or 3rd degree atrioventricular block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; Uncontrolled hypertension.
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin, pomalidomide, dexamethasone or any of the components of the study intervention.
Pregnant or lactating female.
Active infection requiring treatment.
Known human immunodeficiency virus (HIV), unless the participant can meet all of the following criteria: Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load <400 copiesmL; CD4+ T-cell (CD4+) counts ≥350 cellsuL; No history of AIDS-defining opportunistic infections within the last 12 months.(Consideration must be given to ART and prophylactic antimicrobials that may have a drug-drug interaction or overlapping toxicities with belantamab mafodotin other combination products as relevant)
Participants with Hepatitis B will be excluded unless the following criteria can be met: If the participant is hepatitis B core antibody (HbcAb) positive or hepatitis B surface antigen (HbsAg) negative, then hepatitis B virus (HBV) deoxyribonucleic acid (DNA) should be undectectable at the time of screening; If HbsAg+ at screening or <=3 months prior to first dose of study treatment, then HBV DNA should be undetectable, highly effective antiviral treatment should be started ≥4 weeks prior to first dose of study treatment, exclusion of participants with cirrhosis and participants in Japan must test hepatitis B e antigen (HBeAg) and hepatitis B e antibody (HBeAb ).
Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment unless the participant can meet the following criteria: Hepatitis C RNA test negative at Screening and successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks (Hepatitis RNA is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing).
Participants unable to tolerate thromboembolic prophylaxis.
Current corneal epithelial disease except for mild punctate keratopathy.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 164 Locations for this study
Tucson Arizona, 85715, United States
Santa Barbara California, 93105, United States
Pueblo Colorado, 81008, United States
Plantation Florida, 33322, United States
Detroit Michigan, 48202, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89169, United States
Albany New York, 12208, United States
Lake Success New York, 10042, United States
Cincinnati Ohio, 45236, United States
Eugene Oregon, 97401, United States
Salem Oregon, 97301, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
Tyler Texas, 75702, United States
Milwaukee Wisconsin, 53226, United States
Gosford New South Wales, 2250, Australia
Liverpool New South Wales, 2170, Australia
St Leonards New South Wales, 2065, Australia
Wollongong New South Wales, 2500, Australia
North Adelaide South Australia, 5006, Australia
Woodville South Australia, 5011, Australia
Hobart Tasmania, 7000, Australia
Clayton Victoria, 3168, Australia
Fitzroy Victoria, 3065, Australia
Geelong Victoria, 3220, Australia
Melbourne Victoria, 3004, Australia
Nedlands Western Australia, 6009, Australia
St. Albans , 03021, Australia
Brugge , 8000, Belgium
Bruxelles , 1200, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Jette , 1090, Belgium
Kortrijk , 8500, Belgium
Yvoir , 5530, Belgium
Fortaleza Ceará, 60115, Brazil
Curitiba Paraná, 03089, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Rio de Janeiro , 21941, Brazil
Rio de Janeiro , 22793, Brazil
São Paulo , 01321, Brazil
São Paulo , 01509, Brazil
São Paulo , 04537, Brazil
São Paulo , 05651, Brazil
Pleven , 5800, Bulgaria
Plovdiv , 4000, Bulgaria
Sofia , 01431, Bulgaria
Sofia , 1000, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1606, Bulgaria
Edmonton Alberta, T6G 1, Canada
Guangzhou Guangdong, 51008, China
Changchun Jilin, 13001, China
Beijing , 10019, China
Beijing , 10073, China
Chengdu , 61004, China
Hangzhou , 31000, China
Tianjin , 30002, China
Tianjin , 30006, China
Zhengzhou , 45005, China
Amiens cedex 1 , 80054, France
Créteil cedex , 94010, France
Grenoble cedex 9 , 38043, France
Le Mans , 72015, France
Limoges cedex , 87042, France
Montpellier , 34295, France
Parris Cedex 12 , 75571, France
Poitiers cedex , 86021, France
Tuebingen Baden-Wuerttemberg, 72076, Germany
Ulm Baden-Wuerttemberg, 89081, Germany
Wuerzburg Bayern, 97080, Germany
Mainz Rheinland-Pfalz, 55101, Germany
Berlin , 13125, Germany
Hamburg , 20246, Germany
Athens , 10676, Greece
Athens , 115 2, Greece
Haidari, Athens , 12462, Greece
Larisa , 41 11, Greece
Patra , 26500, Greece
Thessaloniki , 54007, Greece
Thessaloniki , 57010, Greece
Budapest , 1083, Hungary
Budapest , 1088, Hungary
Budapest , 1097, Hungary
Debrecen , 4012, Hungary
Kaposvár , 7400, Hungary
Nyiregyhaza , 4400, Hungary
Catanzaro Calabria, 88100, Italy
Bologna Emilia-Romagna, 40138, Italy
Meldola (FC) Emilia-Romagna, 47014, Italy
Ravenna Emilia-Romagna, 48123, Italy
Roma Lazio, 00161, Italy
Brescia Lombardia, 25123, Italy
Milano Lombardia, 20141, Italy
Pavia Lombardia, 27100, Italy
Ancona Marche, 60126, Italy
San Giovanni Rotondo Puglia, 71013, Italy
Siena Toscana, 53100, Italy
Terni Umbria, 05100, Italy
Milano , 20122, Italy
Aichi , 467-8, Japan
Chiba , 277-8, Japan
Ehime , 790-8, Japan
Fukushima , 960-1, Japan
Gifu , 503-8, Japan
Gunma , 377-0, Japan
Hokkaido , 060-8, Japan
Kyoto , 602-8, Japan
Kyoto , 603-8, Japan
Osaka , 565-0, Japan
Saitama , 350-8, Japan
Tokushima , 770-8, Japan
Tokyo , 108-8, Japan
Tokyo , 135-8, Japan
Tokyo , 150-8, Japan
Goyang-si, Gyeonggi-Do , 410-7, Korea, Republic of
Hwasun , 58128, Korea, Republic of
Incheon , 405-7, Korea, Republic of
Seongnam-si, Gyeonggi-do , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06591, Korea, Republic of
Amersfoort , 3813 , Netherlands
Rotterdam , 3015 , Netherlands
Gdansk , 80-95, Poland
Krakow , 30510, Poland
Krakow , 31-50, Poland
Torun , 87-10, Poland
Warszawa , 02106, Poland
Ekaterinburg , 62010, Russian Federation
Kaluga , 24800, Russian Federation
Kemerovo , 65006, Russian Federation
Kirov , 61002, Russian Federation
Krasnoyarsk , 66002, Russian Federation
Nizhny Novgorod , 60313, Russian Federation
Novosibirsk , 63008, Russian Federation
Saint Petersburg , 19734, Russian Federation
Samara , 44302, Russian Federation
Sochi , 35405, Russian Federation
St'Petersburg , 19102, Russian Federation
Syktyvkar , 16790, Russian Federation
Tula , 30005, Russian Federation
Yaroslavl , 15006, Russian Federation
Badalona , 08916, Spain
Barcelona , 08036, Spain
Hospitalet de Llobregat (Barcelona) , 08908, Spain
Malaga , 29004, Spain
Pamplona , 31008, Spain
Pozuelo De Alarcón/Madrid , 28223, Spain
Salamanca , 37007, Spain
Santiago de Compostela , 15706, Spain
Valencia , 46017, Spain
Airdrie Lanarkshire, ML6 0, United Kingdom
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom
Dundee , DD1 9, United Kingdom
Edinburgh , EH4 2, United Kingdom
London , EC1 7, United Kingdom
London , W12 0, United Kingdom
Manchester , M20 4, United Kingdom
Nottingham , NG5 1, United Kingdom
Oxford , OX3 7, United Kingdom
Plymouth , PL6 8, United Kingdom
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.