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NCT Number: NCT06215118

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)

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Liverpool Hospital, Liverpool, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elranatamab

Drug

BCMA-CD3 bispecific antibody

Other names: PF-06863135

Iberdomide

Drug

cereblon-modulating agent

Other names: CC-220, BMS-986382

Primary outcomes

  1. Part 1: Number of participants with dose limiting toxicity (DLT)

    Time frame: Cycle 1, about 28 days

    Dose limiting toxicity rate based on dose limiting toxicity evaluable participants

  2. 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

    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.

Secondary outcomes

  1. Part 1: 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

    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.

  2. Part 1 and Part 2: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity

    Time frame: Assessed from baseline up to 90 days after last dose of study treatment

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibly of causal relationship

  3. Part 1 and Part 2: Number of Participants with Clinically Significant Change from Baseline in Laboratory Abnormalities

    Time frame: Assessed from baseline up to 90 days after last dose of study treatment

    Laboratory abnormalities as characterized by type, frequency, severity

  4. Part 1 and Part 2: Percentage of Participants with Objective Response Rate (ORR)

    Time frame: Assessed for approximately 2 years

    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

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

    Time frame: Assessed for approximately 2 years

    Percent of participants having Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria as determined by investigator

  6. Part 1 and Part 2: Time to Response (TTR)

    Time frame: Assessed for approximately 2 years

    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

  7. Part 1 and Part 2: Duration of Response (DOR)

    Time frame: Assessed for approximately 2 years

    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

  8. Part 1 and Part 2: Duration of Complete Response (DOCR)

    Time frame: Assessed for approximately 2 years

    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

  9. Part 1 and Part 2: Time of Progression Free Survival (PFS)

    Time frame: Assessed for approximately 2 years

    Progression free survival (IMWG criteria)

  10. Part 1 and Part 2: Time of Overall Survival (OS)

    Time frame: Assessed for approximately 2 years

    The duration of time from first dose of study treatment to death

  11. Part 1 and Part 2: Minimal Residual Disease (MRD) Negativity Rate

    Time frame: Assessed for approximately 2 years

    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.

  12. Part 1 and Part 2: Concentrations of elranatamab

    Time frame: Assessed for approximately 2 years

    Pre-dose and post-dose concentrations of elranatamab

  13. Part 1 and Part 2: Concentrations of iberdomide

    Time frame: Assessed for approximately 4 months

    Pre-dose concentrations of iberdomide

  14. Part 1 and Part 2: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab

    Time frame: Assessed for approximately 2 years

    Percent of participants with positive ADA to elranatamab when given in combination with iberdomide

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jan 22, 2024
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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