A study to investigate the safety and efficacy of belantamab for the treatment of multiple myeloma when used as monotherapy and in combination treatments

JRCT ID: jRCT2051230065

Registered date:07/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 31/08/2023
• Target sample size: 124
• Countries of recruitment: Poland,Japan,Turkey,Japan,Brazil,Japan,United Kingdom,Japan,Republic of Korea,Japan,Taiwan,Japan,Australia,Japan,Mexico,Japan,Argentina,Japan
• Study type: Interventional

Intervention(s)

Part1:
Drug: Belantamab
Drug: Belantamab mafodotin
Part2,3:
Drug: Belantamab
Drug: Belantamab mafodotin
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Either standard of care (SoC) or an emerging treatment for Multiple Myeloma

Outcome(s)

Primary Outcome

Part 1, 2 and 3:
-Number of Participants with any Adverse Event
-Number of Participants with Worst Case Grade Change from Baseline in Laboratory and Vital Sign Parameters
Part 1:
-Number of Participants with Dose Limiting Toxicities (DLTs)
Part 2 and 3:
-Number of Participants with Corneal Adverse Events (CAEs)

Secondary Outcome

Part 1, 2 and 3:
-Objective Response Rate (ORR)
-Observed Plasma Concentration of Belantamab
-Area Under the Curve (AUC) of Belantamab
-Maximum Concentration (Cmax) of Belantamab
-Number of Participants with Anti-Drug Antibodies (ADA) against Belantamab
-Titers of ADA against Belantamab

Part 2 and 3:
-Stringent Complete Response (sCR) Rate
-Complete Response (CR) Rate
-Very Good Partial Response (VGPR) Rate
-Observed Plasma Concentration of Belantamab mafodotin
-Number of Participants with ADAs against Belantamab mafodotin
-Titers of ADAs against Belantamab mafodotin

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-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.

Exclude criteria

-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.

Related Information

• Primary Sponsor: Ishibashi Hideyasu
• Secondary ID(s): NCT05714839