Recruiting
Phase 1

Elranatamab & Iberdomide

Sponsor:

Pfizer

Code:

NCT06215118

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elranatamab

Iberdomide

Study Details

Brief summary:

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.

Conditions

Multiple Myeloma

Study ID

NCT06215118

Start date

Feb 20, 2024

Status verified date

Jun, 2026

Completion date

Mar 9, 2028

Anticipated

Primary completion date

Apr 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

87 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 Dose Escalation

Non-randomized elranatamab plus iberdomide

experimental: Part 2 Dose Randomization

Randomized elranatamab plus iberdomide

Interventions

Elranatamab

BCMA-CD3 bispecific antibody

Iberdomide

cereblon-modulating agent

Primary outcome measure

  • Part 1: Number of participants with dose limiting toxicity (DLT) [ Time Frame: Cycle 1, about 28 days ]
  • Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment [ Time Frame: Assessed from baseline up to 90 days after last dose of study treatment ]

Central Contacts and Locations

Central contacts

Locations

Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

Recruiting

Coral Gables, Florida, United States, 33146

University of Miami Hospital and Clinics Deerfield Beach

Recruiting

Deerfield Beach, Florida, United States, 33442

Sylvester Comprehensive Cancer Center- Doral

Recruiting

Doral, Florida, United States, 33166

Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

University of Miami Hospital and Clinics

Recruiting

Miami, Florida, United States, 33136

Sylvester Comprehensive Cancer Center Kendall

Recruiting

Miami, Florida, United States, 33176

Sylvester Comprehensive Cancer Center Plantation

Recruiting

Plantation, Florida, United States, 33324

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Indiana CTSI Clinical Research Center (ICRC)

Recruiting

Indianapolis, Indiana, United States, 46202

Indiana University Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC)

Recruiting

Indianapolis, Indiana, United States, 46202

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Dana-Farber Cancer Institute - Chestnut Hill

Recruiting

Newton, Massachusetts, United States, 02459

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Methodist Hospital

Recruiting

Omaha, Nebraska, United States, 68114

Oncology Hematology West P.C. dba Nebraska Cancer - Methodist

Recruiting

Omaha, Nebraska, United States, 68114

Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

MSK Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

MSK Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

MSK Bergen

Recruiting

Montvale, New Jersey, United States, 07645

MSK Commack

Recruiting

Commack, New York, United States, 11725

MSK Westchester

Recruiting

Harrison, New York, United States, 10604

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Recruiting

Long Island City, New York, United States, 11101

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

Recruiting

New York, New York, United States, 10021

Memorial Sloan Kettering Cancer Center - Main Campus

Recruiting

New York, New York, United States, 10065

MSK Nassau

Recruiting

Uniondale, New York, United States, 11553

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Dr. Everett Chalmers Regional Hospital

Recruiting

Fredericton, New Brunswick, Canada, E3B 5N5

CIUSSS de l'Est-de-l'Île-de-Montréal

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

Pfizer

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • elranatamab
  • PF-06863135
  • iberdomide
  • relapsed
  • refractory
  • RRMM
  • BCMA
  • MagnetisMM
  • Bispecific antibody
  • CC-220

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-06-10.