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

Launched by PETHEMA FOUNDATION · Feb 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a new treatment called elranatamab for patients with relapsed or refractory multiple myeloma, which means their cancer has come back or hasn't improved after previous treatments. Participants in this study must have already undergone at least one or two different types of therapy and should have received treatment from specific drug classes, including immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy. To be eligible, patients must also be at least 18 years old and have measurable signs of their disease.

During the trial, participants will receive elranatamab through injections and will be monitored closely for any side effects and how well the treatment is working. The study will look for signs of the disease decreasing, as well as track any serious reactions or complications. Patients can expect to be involved in the study for a period that includes a baseline assessment, treatment sessions, and follow-up evaluations. Importantly, they will have the option to withdraw from the study at any time without affecting their regular medical care.

Gender

ALL

Eligibility criteria

• 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 protocol requirements.
• • Prior diagnosis of MM as defined according to IMWG criteria.
• • Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
• • Relapse multiple myeloma patients that have received at least 1 or 2 prior lines of therapy including at least to one proteasome inhibitor (bortezomib, carfilzomib or ixazomib), one immunomodulatory drug (lenalidomide is mandatory and patients can be also 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 while receiving treatment or in the first 60 days after the last dose of treatment.
• • Patient must have a measurable secretory disease defined as either serum monoclonal protein of ≥ 0,5 g/dl or urine monoclonal (light chain) protein ≥ 200 mg/24 h. For patients 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 undetermined significance (MGUS), smoldering multiple myeloma (SMM), POEMS syndrome (defined by the presence of peripheral neuropathy, organomegaly, endocrinopathy, monoclonal plasma-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 by the 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 ≥3 peripheral motor polyneuropathy.
• • Stem cell transplant within 12 weeks prior to enrolment.