Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes

Inclusion Criteria:

• Male or female, 18 years or older (at the time consent is obtained).
• Patient who, in the investigator's opinion, is able to comply with the protocolrequirements.
• Prior diagnosis of MM as defined according to IMWG criteria.
• Patient has given voluntary written informed consent before performance of anystudy-related procedure not part of normal medical care, with the understanding thatconsent may be withdrawn by the patient at any time without prejudice to their futuremedical care.
• Relapse multiple myeloma patients that have received at least 1 or 2 prior lines oftherapy including at least to one proteasome inhibitor (bortezomib, carfilzomib orixazomib), one immunomodulatory drug (lenalidomide is mandatory and patients can bealso have been exposed to pomalidomide) and at least one anti-CD38 monoclonal antibody (daratumumab or isatuximab).
• Patients must be refractory to the last line of therapy, defined as progression whilereceiving treatment or in the first 60 days after the last dose of treatment.
• Patient must have a measurable secretory disease defined as either serum monoclonalprotein of ≥ 0,5 g/dl or urine monoclonal (light chain) protein ≥ 200 mg/24 h. Forpatients in whom disease is only measurable by serum FLC, the involved FLC should be ≥ 10mg/dL (100 mg/L), with an abnormal serum FLC ratio.

Exclusion Criteria:

• Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undeterminedsignificance (MGUS), smoldering multiple myeloma (SMM), POEMS syndrome (defined by thepresence of peripheral neuropathy, organomegaly, endocrinopathy, monoclonalplasma-cells proliferative disorder, and skin changes) or plasma cell leukemia.
• Prior anti-BCMA treatment.
• Subject has peripheral neuropathy or neuropathic pain grade 2 or higher, as defined bythe National Cancer Institute Terminology Criteria for Adverse Events (NCI CTCAE)Version 5.
• History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3peripheral motor polyneuropathy.
• Stem cell transplant within 12 weeks prior to enrolment.