Title
A Phase 3, Open-Label Study of Elranatamab Monotherapy Versus Elotuzumab, Pomalidomide, Dexamethasone (EPd) or Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed/ Refractory Multiple Myeloma Who Received Prior Anti-CD38 Directed Therapy

Description
A Phase 3, Open-Label Study of Elranatamab Monotherapy Versus Elotuzumab, Pomalidomide, Dexamethasone (Epd) or Pomalidomide, Bortezomib, Dexamethasone (Pvd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed/Refractory Multiple Myeloma Who Received Prior Anti-CD38 Directed Therapy

Objective
The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).

Treatment Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM.

Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study.

The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:

a shot under the skin at the study clinic

through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.

Key Eligibility Inclusion Criteria:

Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.

Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.

Measurable disease defined as at least 1 of the following: (a) Serum M-protein >/=0.5 g/dL; (b) Urinary M-protein excretion >/=200 mg/24 hours; (c) Serum involved immunoglobulin FLC >/=10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).

Have clinical laboratory values within the specified range.

ECOG (Eastern Cooperative Oncology Group) performance status
Not pregnant or breastfeeding and willing to use contraception.

Applicable Disease Sites
Multiple Myeloma

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital