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Carfilzomib, Lenalidomide, Dexamethasone, Belantamab Mafodotin

Phase I - Chemotherapy multiple agents systemic Phase II - Maximum Tolerated Dose from Phase I

Shebli Atrash, MD, MS

This research study is being done to learn if the study drug belantamab mafodotin, in combination with other standard medications, can improve multiple myeloma. This study will also help determine what effects, good and/or bad, this combination of study drugs have on subjects and their cancer, and to evaluate the overall response to this study treatment combination.

This is a phase I dose escalation and expansion study in RMM and RRMM followed by a single arm phase II expansion in high risk, NDMM. The phase I portion of the protocol will utilize a standard 3+3 dose escalation design to determine the maximum tolerated dose (MTD) and RP2D of the KRd-belantamab mafodotin combination. The phase II portion of the trial is a two-stage design that will assess the efficacy and safety of the combination in newly diagnosed, high-risk MM patients.

Study of Carfilzomib, Lenalidomide, Dexamethasone and Belantamab Mafodotin in Multiple Myeloma

A Phase I/II Study of Carfilzomib, Lenalidomide, Dexamethasone and the Anti-B-Cell Maturation Antigen (BCMA) Antibody Drug Conjugate Belantamab Mafodotin in Multiple Myeloma

The SAE variable will be determined for each subject as a binary variability indicating whether or not subject experienced a protocol-defined SAE.

The AE variable will be determined for each subject as a binary variability indicating whether or not subject experienced an AE per CTCAE V5.0.

The AESI variable will be determined for each subject as a binary variability indicating whether or not subject experienced a protocol-defined AESI.

Describe subject outcomes of progression free survival and overall survival for MRD concordant and discordant cases

Compare MRD status concordance between NGF and QiP mass spectrometry

Assess BCMA (B Cell Maturation Antigen) expression by plasma cells prior to therapy and at relapse using formalin-fixed paraffin embedded (FFPE) bone marrow biopsies.

Establish peripheral blood and bone marrow immunologic profiles throughout therapy.

Correlate plasma cell BCMA (B Cell Maturation Antigen) expression with Progression Free Survival (PFS) and Overall Survival (OS).

Correlate serum cell sBCMA (serum B Cell Maturation Antigen) concentration with Progression Free Survival (PFS) and Overall Survival (OS).

DLTs will be determined for each subject enrolled in Phase I as a binary variable indicating whether the subject experienced a DLT during Cycle 1 of belantamab mafodotin-containing protocol directed induction therapy.

CR will be determined for each subject as a binary variable indicating whether the achieved a best overall response to induction therapy of CR or better.

CR will be determined for each subject as a binary variable indicating whether the achieved a best overall response to induction therapy of CR or better

The best overall response will be determined as an ordered categorial variable indicating the subject's best response at any point along the treatment continuum.

will be determined for each subject as a binary variable indicating whether the achieved a best overall response to induction therapy of VGPR or better.

The best overall response will be determined as an ordered categorial variable indicating the subject's best response at any point along the treatment continuum

. Minimal residual disease (MRD) (via NGF 10-5 and 10-6) will be determined for each subject after suspected CR for Phase I subjects and at the following timepoints for Phase II subjects: after induction therapy, after ASCT, and after 12 cycles of maintenance therapy (post Cycle 18visit) and every 12 months post Cycle 18 sample.

TTFR will be calculated for all subjects achieving an sCR, CR, VGPR, or PR. This will be defined as the time from initiation of belantamab mafodotin-containing protocol directed induction therapy to the time of first disease assessment indicating either sCR, CR, VGPR or PR

Time to best response will be calculated for all subjects achieving an sCR, CR, VGPR or PR. This will be defined as the time from initiation of belantamab mafodotin-containing protocol directed induction therapy to the time of best disease assessment indicating either sCR, CR, VGPR or PR.

TTP is defined as the duration of time from enrollment to the study (treatment start date) to first occurrence of progressive disease

DoR will be calculated for each subject achieving a PR or better and will be calculated from the time of the first assessment that identified response until disease progression or death.

OS is defined as the duration from enrollment to the study (treatment start date) to the date of death from any cause.

PFS is defined as the duration of time from enrollment to the study (treatment start date) to first occurrence of either progressive disease or death (from any cause), whichever comes first.

Spots Global Cancer Trial Database for carfilzomib, lenalidomide, dexamethasone, belantamab mafodotin