MAGNETISMM-1 A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH IMMUNOMODULATORY AGENTS IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)

C1071001

To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

2017-11-29

2024-01-19

2024-01-19

Completed

Early phase I

101

Inclusion Criteria: * Relapsed/refractory multiple myeloma * Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody * Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma) * Adequate bone marrow, hematological, kidney and liver function * Resolved acute effects of any prior therapy to baseline severity * Not pregnant Exclusion Criteria: * Recent history of other malignancies * History of active autoimmune disorders * Any form of primary immunodeficiency * Active and clinically significant bacterial, fungal, or viral infection * Evidence of active mucosal or internal bleeding * History of severe immune-mediated adverse event with prior immunomodulatory treatment * Major surgery within 4 weeks of study treatment start * Radiation therapy within 2 weeks of study treatment start * History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment * Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry * Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy * Requirement for systemic immune suppressive medication except as permitted in the protocol * Current requirement for chronic blood product support

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 101, 'type': 'ACTUAL'}}

2024-02-23