MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb

Pfizer

Status and phase: Active, not recruiting; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Elranatamab (PF-06863135)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04649359

MagnetisMM-3 (Other Identifier)

2020-004533-21 (EudraCT Number)

C1071003

Details and patient eligibility

About

The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)

• Measurable disease, as defined by at least 1 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

• Refractory to at least one IMiD

• Refractory to at least one PI

• Refractory to at least one anti-CD38 antibody

• Relapsed/refractory to last anti-myeloma regimen

• Cohort A: has not received prior BCMA-directed therapy

• Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)

• ECOG performance status ≤2

• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1

• Not pregnant and willing to use contraception

Exclusion criteria

• Smoldering multiple myeloma
• Active Plasma cell leukemia
• Amyloidosis
• POEMS syndrome
• Stem cell transplant within 12 weeks prior to enrollment
• Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
• Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
• Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Elranatamab (cohort A)

Experimental group

Description:

BCMA-CD3 bispecific antibody

Treatment:

Drug: Elranatamab (PF-06863135)

Elranatamab (cohort B)

Experimental group

Description:

BCMA-CD3 bispecific antibody

Treatment:

Drug: Elranatamab (PF-06863135)