A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)

Study Purpose

The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide. There are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma. Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement. All study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle. Participants will receive study medicine until:

  • - their disease progresses or, - they experience unacceptable side effects or, - they choose to no longer take part in the study.
The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Prior diagnosis of multiple myeloma as defined by IMWG criteria.
  • - Measurable disease based on IMWG criteria as defined by at least 1 of the following: - Serum M-protein ≥0.5 g/dL by SPEP.
  • - Urinary M-protein excretion ≥200 mg/24 hour by UPEP.
  • - Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (<0.26 or >1.65) - Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
  • - Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
  • - ECOG performance status 0-1.
  • - Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.

Exclusion Criteria:

  • - Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome.
  • - Impaired cardiovascular function or clinically significant cardiovascular diseases.
  • - Stem cell transplant within 12 weeks prior to enrollment or active graft vs.host disease.
  • - Participants with 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 treatment with: - BCMA-directed or CD3 redirecting therapy.
  • - Iberdomide (CC-220) or Mezigdomide.
  • - Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study.
  • - Administration with an investigational product within 30 days preceding the first dose of study intervention.
- Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06215118
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Part 1 Dose Escalation

Non-randomized elranatamab plus iberdomide

Experimental: Part 2 Dose Randomization

Randomized elranatamab plus iberdomide

Interventions

Drug: - Elranatamab

BCMA-CD3 bispecific antibody

Drug: - Iberdomide

cereblon-modulating agent

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

MSK Basking Ridge, Basking Ridge, New Jersey

Status

Not yet recruiting

Address

MSK Basking Ridge

Basking Ridge, New Jersey, 07920

MSK Monmouth, Middletown, New Jersey

Status

Not yet recruiting

Address

MSK Monmouth

Middletown, New Jersey, 07748

MSK Commack, Commack, New York

Status

Not yet recruiting

Address

MSK Commack

Commack, New York, 11725

MSK Westchester, Harrison, New York

Status

Not yet recruiting

Address

MSK Westchester

Harrison, New York, 10604

Long Island City, New York

Status

Not yet recruiting

Address

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Long Island City, New York, 11101

New York, New York

Status

Not yet recruiting

Address

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

New York, New York, 10021

New York, New York

Status

Not yet recruiting

Address

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, 10065

International Sites

Dr. Everett Chalmers Regional Hospital, Fredericton, New Brunswick, Canada

Status

Recruiting

Address

Dr. Everett Chalmers Regional Hospital

Fredericton, New Brunswick, E3B 5N5