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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
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

NCT04649359

Active Not RecruitingPhase 2

Sponsor: Pfizer

Conditions: Multiple Myeloma

Interventions: Elranatamab (PF-06863135)

Countries: United States, Australia, Canada, France, Germany, Japan, Poland, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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)
Locations (40)
  • Beverly Hills, California, United States
  • Irvine, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Maywood, Illinois, United States
  • Maywood, Illinois, United States
  • Louisville, Kentucky, United States
  • New Orleans, Louisiana, United States
  • Hackensack, New Jersey, United States
  • Long Island City, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Greenville, South Carolina, United States
  • Dallas, Texas, United States
  • Fitzroy, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Richmond, Victoria, Australia
  • Montreal, Quebec, Canada
  • Montreal, Quebec, Canada
  • Lille, France
  • Nantes, France
  • Pierre-Bénite, France
  • Poitiers, France
  • + 10 more on CT.gov