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A study of a combination of Belantamab Mafodotin with Pomalidomide and Dexamethasone (B-Pd) compared to Bortezomib with Pomalidomide and Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma
EU CTIS ID: 2023-506877-37-00
What this study is testing
To compare the efficacy of B-Pd with that of PVd in participants with RRMM
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Capable of giving signed informed consent
- Male and female participants agree to abide by protocol-defined contraceptive requirements
- 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 therap. (Participants treated with lenalidomide ≥ 10mg daily for at least 2 consecutive cycles are eligible)
You likely can't join if
- Active plasma cell leukaemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening
- 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 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, eoshageal or gastric varices, persistent jaundice
- Active infection requiring treatment
See the full eligibility criteria
Who can join
- Capable of giving signed informed consent
- Male and female participants agree to abide by protocol-defined contraceptive requirements
- 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 therap. (Participants treated with lenalidomide ≥ 10mg daily 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 g/Liter [L]), or 3.Serum free light chain (FLC) assay: involved FLC level ≥10mg/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 considering 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
What rules you out
- Active plasma cell leukaemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening
- 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 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, eoshageal 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 peripheral venous and arterial thromboebolism within the past 3 months
- Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis
- Prior allogeneic SCT
- 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
- 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
- Plasmapharesis 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: 1.Evidence of current clinically significant untreated arrhythmias, including clinically 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, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting 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
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- New Zealand
- Israel
- United Kingdom
- Brazil
- United States
- Russian Federation
- Turkey
- Korea, Republic of
- Australia
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; New Zealand; Israel; United Kingdom; Brazil; United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.