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)

A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH IBERDOMIDE IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Elranatamab; Drug: Iberdomide

• Study Type: Interventional
• Enrollment (Estimated): 87
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Recruiting
      • Liverpool Hospital
    • Waratah, New South Wales, Australia, 2298
      • Recruiting
      • Calvary Mater Newcastle
  • Queensland
    • Douglas, Queensland, Australia, 4814
      • Recruiting
      • Townsville University Hospital
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Recruiting
      • Epworth Freemasons
    • Richmond, Victoria, Australia, 3121
      • Recruiting
      • Slade Pharmacy
    • Richmond, Victoria, Australia, 3121
      • Recruiting
      • Epworth Hospital
• Canada
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 5N5
      • Recruiting
      • Dr. Everett Chalmers Regional Hospital
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • CIUSSS de l'Est-de-l'Île-de-Montréal
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Recruiting
      • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer
• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
    • Deerfield Beach, Florida, United States, 33442
      • Recruiting
      • University of Miami Hospital and Clinics Deerfield Beach
    • Doral, Florida, United States, 33166
      • Recruiting
      • Sylvester Comprehensive Cancer Center- Doral
    • Miami, Florida, United States, 33136
      • Recruiting
      • Sylvester Comprehensive Cancer Center
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Hospital and Clinics
    • Miami, Florida, United States, 33176
      • Recruiting
      • Sylvester Comprehensive Cancer Center Kendall
    • Plantation, Florida, United States, 33324
      • Recruiting
      • Sylvester Comprehensive Cancer Center Plantation
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Winship Cancer Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Health University Hospital
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana CTSI Clinical Research Center (ICRC)
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC)
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
    • Newton, Massachusetts, United States, 02459
      • Recruiting
      • Dana-Farber Cancer Institute - Chestnut Hill
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • University of Massachusetts Chan Medical School
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Recruiting
      • Oncology Hematology West P.C. dba Nebraska Cancer Specialists
    • Omaha, Nebraska, United States, 68114
      • Recruiting
      • Methodist Hospital
    • Omaha, Nebraska, United States, 68114
      • Recruiting
      • Oncology Hematology West P.C. dba Nebraska Cancer - Methodist
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • MSK Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • MSK Monmouth
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • MSK Bergen
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • MSK Commack
    • Harrison, New York, United States, 10604
      • Recruiting
      • MSK Westchester
    • Long Island City, New York, United States, 11101
      • Recruiting
      • Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center - Main Campus
    • New York, New York, United States, 10021
      • Recruiting
      • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
    • Uniondale, New York, United States, 11553
      • Recruiting
      • MSK Nassau
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Dose Escalation; Non-randomized elranatamab plus iberdomide	Drug: Elranatamab; BCMA-CD3 bispecific antibody; Other Names: PF-06863135; Drug: Iberdomide; cereblon-modulating agent; Other Names: CC-220; BMS-986382
Experimental: Part 2 Dose Randomization; Randomized elranatamab plus iberdomide	Drug: Elranatamab; BCMA-CD3 bispecific antibody; Other Names: PF-06863135; Drug: Iberdomide; cereblon-modulating agent; Other Names: CC-220; BMS-986382

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of participants with dose limiting toxicity (DLT)	Dose limiting toxicity rate based on dose limiting toxicity evaluable participants	Cycle 1, about 28 days
Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment	Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator.	Assessed from baseline up to 90 days after last dose of study treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment	Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator.	Assessed from baseline up to 90 days after last dose of study treatment
Part 1 and Part 2: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibly of causal relationship	Assessed from baseline up to 90 days after last dose of study treatment
Part 1 and Part 2: Number of Participants with Clinically Significant Change from Baseline in Laboratory Abnormalities	Laboratory abnormalities as characterized by type, frequency, severity	Assessed from baseline up to 90 days after last dose of study treatment
Part 1 and Part 2: Percentage of Participants with Objective Response Rate (ORR)	Percent of participants having confirmed Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) per IMWG criteria as determined by investigator	Assessed for approximately 2 years
Part 1 and Part 2: Percentage of Participants with Complete Response Rate (CRR)	Percent of participants having Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria as determined by investigator	Assessed for approximately 2 years
Part 1 and Part 2: Time to Response (TTR)	For participants with an objective response per IMWG criteria, TTR is the time from first dose to the first documentation of objective response that is subsequently confirmed	Assessed for approximately 2 years
Part 1 and Part 2: Duration of Response (DOR)	For participants with an objective response per IMWG criteria, DOR is the time from first documentation of objective response that is subsequently confirmed until the first documentation of confirmed progressive disease (PD) per IMWG criteria	Assessed for approximately 2 years
Part 1 and Part 2: Duration of Complete Response (DOCR)	For participants with a Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria, DOCR is the time from the first documentation of CR/sCR that is subsequently confirmed until the first documentation of confirmed progressive disease (PD) per IMWG criteria	Assessed for approximately 2 years
Part 1 and Part 2: Time of Progression Free Survival (PFS)	Progression free survival (IMWG criteria)	Assessed for approximately 2 years
Part 1 and Part 2: Time of Overall Survival (OS)	The duration of time from first dose of study treatment to death	Assessed for approximately 2 years
Part 1 and Part 2: Minimal Residual Disease (MRD) Negativity Rate	The proportion of participants achieving CR+sCR with negative MRD per IMWG sequencing criteria, from the date of first dose until the first documentation of confirmed progressive disease (PD), death, or start of new anticancer therapy.	Assessed for approximately 2 years
Part 1 and Part 2: Concentrations of elranatamab	Pre-dose and post-dose concentrations of elranatamab	Assessed for approximately 2 years
Part 1 and Part 2: Concentrations of iberdomide	Pre-dose concentrations of iberdomide	Assessed for approximately 4 months
Part 1 and Part 2: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab	Percent of participants with positive ADA to elranatamab when given in combination with iberdomide	Assessed for approximately 2 years

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Bristol-Myers Squibb
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): March 9, 2028

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: CC-220; RRMM; relapsed; refractory; PF-06863135; BCMA; Bispecific antibody; MagnetisMM; elranatamab; iberdomide
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Multiple Myeloma; iberdomide
• Other Study ID Numbers: C1071030 (Alias Study Number); MagnetisMM-30 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No