Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).

This study is seeking participants who:

  • Are 18 years of age or older and have MM.
  • Have received treatments before for MM.
  • Have MM that has returned or not responded to their most recent treatment.

Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM.

Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study.

The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:

  • a shot under the skin at the study clinic
  • through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.

Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits).

The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.

Official Title

A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY

Keywords

Multiple Myeloma, Elranatamab, B-Cell Maturation Antigen, BCMA, Bispecific antibody, BCMA-CD3 bispecific antibody, Myeloma, Relapsed multiple myeloma, Refractory multiple myeloma, MagnetisMM, MagnetisMM-32, Pomalidomide, Elotuzumab, Bortezomib, Carfilzomib, PF-06863135, Plasma Cell Neoplasms, Dexamethasone

Eligibility

You can join if…

Open to people ages 18 years and up

  • Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.
  • Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.
  • Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  • Have clinical laboratory values within the specified range.
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
  • Not pregnant or breastfeeding and willing to use contraception.

You CAN'T join if...

  • Smoldering multiple myeloma.
  • Plasma cell leukemia.
  • Amyloidosis.
  • Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
  • Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.
  • Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
  • Any active, uncontrolled bacterial, fungal, or viral infection.
  • Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
  • Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.
  • Unable to receive investigator's choice therapy.
  • Live attenuated vaccine within 4 weeks of the first dose of study intervention.
  • Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.

Locations

  • University of California Davis (UC Davis) Comprehensive Cancer Center not yet accepting patients
    Sacramento California 95817 United States
  • Beverly Hills Cancer Center accepting new patients
    Beverly Hills California 90211 United States
  • Community Cancer Institute not yet accepting patients
    Clovis California 93611 United States
  • University of California not yet accepting patients
    Sacramento California 95817 United States
  • Longs Peak Hospital accepting new patients
    Longmont Colorado 80504 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT06152575
Phase
Phase 3 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 492 study participants
Last Updated