A study to investigate the safety and efficacy of belantamab for the treatment of multiple myeloma when used as monotherapy and in combination treatments
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-jRCT2051230065
- Lead Sponsor
- Ishibashi Hideyasu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 124
Participants at the time of signing the Informed Consent Form (ICF) are at least 18 years old or are of the legal age of consent in the jurisdiction in which the study is taking place.
-Participants who have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG, and measurable disease.
-PART 1: Participants who have received at least 3 prior lines of anti-myeloma treatments, and have already received an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 mAb (unless contraindicated or unavailable). Lines of therapy are defined by consensus panel of the International Myeloma Workshop.
-PART 2: Participants who meet all of the following:
Have undergone Autologous stem cell transplant (ASCT) or are considered transplant ineligible
Have been previously treated with at least ONE prior line of MM therapy
Have documented disease progression during or after their most recent therapy
-PART 3: Participants who meet both of the following:
-NDMM with a requirement for treatment as documented per IMWG criteria
-Not considered a candidate for high dose chemotherapy with ASCT due to:
Age >- 65 years OR
Age 18-65 years with presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT or who refuse high-dose chemotherapy with ASCT as an initial treatment.
-Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and protocol.
-Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active Polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, primary plasma cell leukemia.
-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.
-Active infection requiring antibiotic, antiviral, or antifungal treatment.
-Known, current drug or alcohol abuse.
-Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this trial, unless prospective Independent Review Board (IRB) approval (by chair or designee) is allowing exception to this criterion for a specific participant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 1, 2 and 3: <br>-Number of Participants with any Adverse Event<br>-Number of Participants with Worst Case Grade Change from Baseline in Laboratory and Vital Sign Parameters<br>Part 1: <br>-Number of Participants with Dose Limiting Toxicities (DLTs)<br>Part 2 and 3: <br>-Number of Participants with Corneal Adverse Events (CAEs)
- Secondary Outcome Measures
Name Time Method Part 1, 2 and 3: <br>-Objective Response Rate (ORR)<br>-Observed Plasma Concentration of Belantamab<br>-Area Under the Curve (AUC) of Belantamab<br>-Maximum Concentration (Cmax) of Belantamab<br>-Number of Participants with Anti-Drug Antibodies (ADA) against Belantamab<br>-Titers of ADA against Belantamab<br><br>Part 2 and 3: <br>-Stringent Complete Response (sCR) Rate<br>-Complete Response (CR) Rate<br>-Very Good Partial Response (VGPR) Rate<br>-Observed Plasma Concentration of Belantamab mafodotin<br>-Number of Participants with ADAs against Belantamab mafodotin<br>-Titers of ADAs against Belantamab mafodotin