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Open-Label, Multicenter, Non-Randomized Phase 2 Study of PF-06863135 Monotherapy in Participants with Multiple Myeloma Who Are Refractory to at Least One Proteasome Inhibitor, One Immunomodulatory Drug and One Anti-CD38 Antibody

Clinical Trial Details

The purpose of this study is to learn about the effects of the study drug (PF-06863135, also called “elranatamab”) for treating multiple myeloma. The study drug (PF-06863135) is an investigational drug because it is not approved for use in this country. The study drug is comprised of two antibodies (sometimes called a “bispecific antibody”). The study drug binds to T-cells (a type of immune system cell) and myeloma cells; this causes the T –cells to kill the myeloma cells.

Depending on the participant’s prior therapy, the participants will be placed in either Cohort A or Cohort B. There is no difference in treatment and procedures for the two cohorts.

During the first week, participants will receive 3 injections of elranatamab (each administered at least 2 days apart). After the first week, participants will receive 1 injection of elranatamab once a week. If a participant received elranatamab for at least 6 months and achieved a partial response or better, participants will receive 1 injection of elranatamab once biweekly. At least once a month, participants will have a physical examination and lab draws to assess for safety and response. Some other procedures that participants will have to complete is electrocardiogram, imaging, electrocardiogram, questionnaires, and bone marrow biopsy. Some of these procedures are part of your routine care for multiple myeloma. Participants will be on this study for at least 2 years. Participants may choose to withdraw at any time or if the study doctor thinks this treatment is no longer beneficial.  

Participants will receive a stipend for each completed study visit if deemed eligible for the study. 

Key Eligibility: 

Inclusion Criteria:

  • Diagnosis of multiple myeloma 
  • Relapsed/refractory to last anti-myeloma regimen
  • Not pregnant and willing to use contraception

Exclusion Criteria:

  • Currently receiving BCMA-directed therapy 
  • Smoldering multiple myeloma
  • Active Plasma cell leukemia
  • Current diagnosis of Amyloidosis or POEMS syndrome
  • Other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.

Detailed eligibility reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Natalie Agudo, RN
646-962-5060
naa9101@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2101023116

ClinicalTrials.gov:

NCT04649359

Sponsor:

C1071003

Status

Closed

Age Group

Adult

Sponsor