MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma

  • Interventional
  • Recruiting
  • NCT05090566
Eligibility Details Visit Clinicaltrials.gov

A PHASE 1B/2, OPEN LABEL UMBRELLA STUDY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, IN COMBINATION WITH OTHER ANTI-CANCER TREATMENTS IN PARTICIPANTS WITH MULTIPLE MYELOMA

The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy

         - Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody

         - Measurable disease defined by at least one of the following:

             1. Serum M-protein >/= 0.5 g/dL by SPEP

             2. Urinary M-protein excretion >/= 200 mg/24 hours by UPEP

             3. Serum immunoglobulin FLC >/= 10 mg/dL (>/= 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio

         - ECOG performance status 0 -1

         - Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade </= 1

        Exclusion Criteria:

         - Active plasma cell leukemia

         - Amyloidosis

         - Stem cell transplant with 12 weeks prior to enrollment, or active GVHD

         - POEMS syndrome

         - Any active uncontrolled bacterial, fungal, or viral infection

         - Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment

         - Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer)

         - Sub-Study A Only: Previous treatment with BCMA bispecific antibody

         - Sub-Study B Only: Previous treatment with BCMA directed therapy

At a Glance

National Government IDNCT05090566

IRB#IRB21-0489

Lead SponsorPfizer

Lead PhysicianAndrzej Jakubowiak

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting