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)

NCT06215118 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: C1071030MagnetisMM-30
• Study Type: interventional
• Target: 87
• Locations: 3 countries
• Sites: 21

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Part 1: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment

  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

  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

  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)

  Assessed for approximately 2 years

• Part 1 and Part 2: Percentage of Participants with Complete Response Rate (CRR)

  Assessed for approximately 2 years

Study Arms (2)

Part 1 Dose Escalation

EXPERIMENTAL

Non-randomized elranatamab plus iberdomide

Drug: Elranatamab; Drug: Iberdomide

Part 2 Dose Randomization

EXPERIMENTAL

Randomized elranatamab plus iberdomide

Drug: Elranatamab; Drug: Iberdomide

Interventions

Elranatamab DRUG

BCMA-CD3 bispecific antibody

Also known as: PF-06863135

Part 1 Dose Escalation; Part 2 Dose Randomization

Iberdomide DRUG

cereblon-modulating agent

Also known as: CC-220, BMS-986382

Part 1 Dose Escalation; Part 2 Dose Randomization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead
• Bristol-Myers Squibb: collaborator

Study Sites (21)

University of Miami Hospital and Clinics Deerfield Beach

Deerfield Beach, Florida, 33442, United States

NOT YET RECRUITING

University of Miami Hospital and Clinics

Miami, Florida, 33136, United States

NOT YET RECRUITING

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

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

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Dana-Farber Cancer Institute - Chestnut Hill

Newton, Massachusetts, 02459, United States

RECRUITING

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

NOT YET RECRUITING

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

Omaha, Nebraska, 68114, United States

RECRUITING

Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

MSK Basking Ridge

Basking Ridge, New Jersey, 07920, United States

RECRUITING

MSK Commack

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Long Island City, New York, 11101, United States

RECRUITING

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

New York, New York, 10021, United States

RECRUITING

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

RECRUITING

Townsville University Hospital

Douglas, Queensland, 4814, Australia

RECRUITING

Epworth Hospital

Richmond, Victoria, 3121, Australia

RECRUITING

Slade Pharmacy

Richmond, Victoria, 3121, Australia

RECRUITING

CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

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

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Related Links

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

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

iberdomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: February 20, 2024
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): March 9, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (15); AU (4)