About this trial
This study is for adults with multiple myeloma (a type of blood cancer) that has come back after being treated earlier or isn't responding to the current treatment.
The main goal is to find out if the study drug, belantamab mafodotin, given less often (on an extended schedule) with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also look at how well the treatment works overall and how safe it is when administered to the participants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, 18 years or older (at the time consent is obtained).
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 zero to 2.
Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or after their most recent therapy.
Disqualifiers
Active plasma cell leukemia at Screening.
Symptomatic amyloidosis, including active Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma proliferative disorder, and Skin changes (POEMS).
The disease must be considered medically stable for at least 2 years; or
The patient must not be receiving active therapy, other than hormonal therapy for this disease.
Trial design
Parallel
Treatments tested in this trial
Belantamab mafodotin
DrugBelantamab mafodotin will be administered.
Dexamethasone
DrugDexamethasone will be administered.
Pomalidomide
DrugPomalidomide will be administered.
Bortezomib
DrugBortezomib will be administered.
Carfilzomib
DrugCarfilzomib will be administered.
Treatment groups
Trial outcomes
Primary outcomes
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed partial response \[PR\] or better (i.e., PR, very good partial response (VGPR), complete response \[CR\], stringent complete response \[sCR\]). Responses will be assessed using International Myeloma Working Group (IMWG) criteria.
Secondary outcomes
Complete Response Rate (CRR)
CRR is defined as the percentage of participants with a confirmed CR or better (i.e., CR, sCR).
Minimal Residual Disease (MRD) Negativity Rate
MRD negativity rate is defined as the percentage of participants who achieve MRD negative status (as assessed by Next generation sequencing \[NGS\] at 10\^-5 threshold) at least once during the time of confirmed CR or better response as per IMWG.
Duration of Response (DoR)
DoR is defined as the time from first documented evidence of PR or better until PD or death due to any cause.
Number of participants with adverse events (AEs), Serious adverse events (SAEs) by severity
Sponsors and contacts
Click on the lead sponsor to view all of their trials.