Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Rel… (NCT05064358) | Clinical Trial Compass
CompletedPhase 2
Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma
United States177 participantsStarted 2022-03-03
Plain-language summary
This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib).
* France specific: participants have failed at least 4 prior lines of anti-myeloma therapies
* Participant has measurable disease per modified IMWG criteria.
* Life expectancy of at least 6 months, in the opinion of the investigator.
* Male and female participants agree to abide by protocol-defined contraceptive requirements.
* Participant is capable of giving signed informed consent.
* Participant meets country-specific inclusion criteria described in the protocol.
Exclusion Criteria:
* Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening.
* Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK).
* Evidence of active mucosal or internal bleeding.
* Pre…
What they're measuring
1
Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale