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).
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 167 Locations for this study
Tucson Arizona, 85712, United States More Info
Principal Investigator
Denver Colorado, 80218, United States More Info
Principal Investigator
Fort Myers Florida, 33901, United States More Info
Principal Investigator
New Port Richey Florida, 34655, United States More Info
Principal Investigator
Pembroke Pines Florida, 33024, United States More Info
Principal Investigator
Coeur d'Alene Idaho, 83814, United States More Info
Principal Investigator
Boston Massachusetts, 02215, United States More Info
Principal Investigator
Kansas City Missouri, 64132, United States More Info
Principal Investigator
Pittsburgh Pennsylvania, 15224, United States More Info
Principal Investigator
Nashville Tennessee, 37203, United States More Info
Principal Investigator
Seattle Washington, 98109, United States More Info
Principal Investigator
Spokane Washington, 99202, United States More Info
Principal Investigator
Milwaukee Wisconsin, 53226, United States More Info
Principal Investigator
Canberra Australian Capital Territory, 2605, Australia More Info
Principal Investigator
Darlinghurst New South Wales, 2010, Australia More Info
Principal Investigator
Gosford New South Wales, 2250, Australia More Info
Principal Investigator
Port Macquarie New South Wales, 2444, Australia More Info
Principal Investigator
Randwick New South Wales, 2031, Australia More Info
Principal Investigator
Wollongong New South Wales, 2500, Australia More Info
Principal Investigator
Benowa Queensland, 4217, Australia More Info
Principal Investigator
South Brisbane Queensland, 4101, Australia More Info
Principal Investigator
Adelaide South Australia, 5000, Australia More Info
Principal Investigator
Fitzroy Victoria, 3065, Australia More Info
Principal Investigator
Geelong Victoria, 3220, Australia More Info
Principal Investigator
Heidelberg Victoria, 3084, Australia More Info
Principal Investigator
Malvern Victoria, 3144, Australia More Info
Principal Investigator
Nedlands Western Australia, 6009, Australia More Info
Principal Investigator
Porto Alegre Rio Grande Do Sul, 90035, Brazil More Info
Principal Investigator
Porto Alegre Rio Grande Do Sul, 90470, Brazil More Info
Principal Investigator
Joinville Santa Catarina, 89201, Brazil More Info
Principal Investigator
Curitiba , 80530, Brazil More Info
Principal Investigator
Rio de Janeiro , 22793, Brazil More Info
Principal Investigator
São Paulo , 01509, Brazil More Info
Principal Investigator
Ottawa Ontario, K1H 8, Canada More Info
Principal Investigator
Toronto Ontario, M5G 2, Canada More Info
Principal Investigator
Montreal , H2X 0, Canada More Info
Principal Investigator
Guangzhou Guangdong, 51006, China More Info
Principal Investigator
Hradec Kralove , 500 0, Czechia More Info
Principal Investigator
Marseille Cedex 9 , 13273, France More Info
Principal Investigator
Périgueux cedex , 24019, France More Info
Principal Investigator
Toulouse cedex 9 , 31059, France More Info
Principal Investigator
Vandeouvre-les-Nancy , 54500, France More Info
Principal Investigator
Heidelberg Baden-Wuerttemberg, 69120, Germany More Info
Principal Investigator
Tuebingen Baden-Wuerttemberg, 72076, Germany More Info
Principal Investigator
Wuerzburg Bayern, 97080, Germany More Info
Principal Investigator
Mainz Rheinland-Pfalz, 55101, Germany More Info
Principal Investigator
Leipzig Sachsen, 04103, Germany More Info
Principal Investigator
Jena Thueringen, 07747, Germany More Info
Principal Investigator
Athens , 115 2, Greece More Info
Principal Investigator
Athens , 11525, Greece More Info
Principal Investigator
Athens , 11527, Greece More Info
Principal Investigator
Ioannina , 45 50, Greece More Info
Principal Investigator
Larisa , 41110, Greece More Info
Principal Investigator
Rio/Patras , 26504, Greece More Info
Principal Investigator
Thessaloniki , 546 3, Greece More Info
Principal Investigator
Thessaloniki , 57010, Greece More Info
Principal Investigator
Haifa , 31096, Israel More Info
Principal Investigator
Jerusalem , 91120, Israel More Info
Principal Investigator
Kfar Saba , 44281, Israel More Info
Principal Investigator
Bologna Emilia-Romagna, 40138, Italy More Info
Principal Investigator
Roma Lazio, 00161, Italy More Info
Principal Investigator
Pavia Lombardia, 27100, Italy More Info
Principal Investigator
San Giovanni Rotondo Puglia, 71013, Italy More Info
Principal Investigator
Busan , 49241, Korea, Republic of More Info
Principal Investigator
Gyeonggi-do , 10408, Korea, Republic of More Info
Principal Investigator
Hwasun-gun, Jeollanam-do , 58128, Korea, Republic of More Info
Principal Investigator
Incheon , 405-7, Korea, Republic of More Info
Principal Investigator
Seoul , 03722, Korea, Republic of More Info
Principal Investigator
Seoul , 06351, Korea, Republic of More Info
Principal Investigator
Seoul , 06591, Korea, Republic of More Info
Principal Investigator
Seoul , 110-7, Korea, Republic of More Info
Principal Investigator
Ulsan , 44033, Korea, Republic of More Info
Principal Investigator
Auckland , 2025, New Zealand More Info
Principal Investigator
Christchurch , 8011, New Zealand More Info
Principal Investigator
Dunedin , 9001, New Zealand More Info
Principal Investigator
Grafton, Auckland , 1023, New Zealand More Info
Principal Investigator
Tauranga , 3143, New Zealand More Info
Principal Investigator
Lublin , 20-09, Poland More Info
Principal Investigator
Kaluga , 24800, Russian Federation More Info
Principal Investigator
Moscow , 12528, Russian Federation More Info
Principal Investigator
Moscow , 12528, Russian Federation More Info
Principal Investigator
Nizhniy Novgorod , 60312, Russian Federation More Info
Principal Investigator
Novosibirsk , 63008, Russian Federation More Info
Principal Investigator
Saint Petersburg , 19734, Russian Federation More Info
Principal Investigator
Samara , 44309, Russian Federation More Info
Principal Investigator
Sochi , 35405, Russian Federation More Info
Principal Investigator
St'Petersburg , 19102, Russian Federation More Info
Principal Investigator
St. Petersburg , 197 0, Russian Federation More Info
Principal Investigator
Tula , 30005, Russian Federation More Info
Principal Investigator
Móstoles Madrid, 28933, Spain More Info
Principal Investigator
Madrid Navarra, 28027, Spain More Info
Principal Investigator
Badalona , 08036, Spain More Info
Principal Investigator
Barcelona , 8035, Spain More Info
Principal Investigator
Gijon , 33204, Spain More Info
Principal Investigator
Hospitalet de Llobregat (Barcelona) , 08908, Spain More Info
Principal Investigator
Murcia , 30008, Spain More Info
Principal Investigator
Palma de Mallorca , 07010, Spain More Info
Principal Investigator
Pamplona , 31008, Spain More Info
Principal Investigator
Pozuelo De Alarcón/Madrid , 28223, Spain More Info
Principal Investigator
Salamanca , 37007, Spain More Info
Principal Investigator
Sevilla , 41013, Spain More Info
Principal Investigator
Valencia , 46026, Spain More Info
Principal Investigator
Southampton Hampshire, SO16 , United Kingdom More Info
Principal Investigator
Airdrie Lanarkshire, ML6 0, United Kingdom More Info
Principal Investigator
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom More Info
Principal Investigator
Sutton Surrey, SM2 5, United Kingdom More Info
Principal Investigator
Bournemouth , BH7 7, United Kingdom More Info
Principal Investigator
London , W12 0, United Kingdom More Info
Principal Investigator
Plymouth , PL6 8, United Kingdom More Info
Principal Investigator
How clear is this clinincal trial information?