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Multiple MyelomaPhase 1NCT06215118

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 1 study testing Elranatamab and Iberdomide in people with Multiple Myeloma, run by Pfizer at 43 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Elranatamab and Iberdomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
43 sitesin 3 countries
Study dates
20 Feb 2024to 15 Oct 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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:
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  • 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 locations and contacts

43 sites in 3 countries.

43 sites in 3 countries

United States34 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • MSK Commack

    Commack, New York, 11725

  • Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

    Coral Gables, Florida, 33146

  • University of Miami Hospital and Clinics Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Sylvester Comprehensive Cancer Center- Doral

    Doral, Florida, 33166

  • MSK Westchester

    Harrison, New York, 10604

  • Indiana CTSI Clinical Research Center (ICRC)

    Indianapolis, Indiana, 46202

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202

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

    Indianapolis, Indiana, 46202

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

    Long Island City, New York, 11101

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

  • Sylvester Comprehensive Cancer Center Kendall

    Miami, Florida, 33176

  • MSK Monmouth

    Middletown, New Jersey, 07748

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • MSK Bergen

    Montvale, New Jersey, 07645

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

    New York, New York, 10021

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York, 10065

  • Dana-Farber Cancer Institute - Chestnut Hill

    Newton, Massachusetts, 02459

  • Methodist Hospital

    Omaha, Nebraska, 68114

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

    Omaha, Nebraska, 68114

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Sylvester Comprehensive Cancer Center Plantation

    Plantation, Florida, 33324

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • University of Washington

    Seattle, Washington, 98195

  • MSK Nassau

    Uniondale, New York, 11553

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

Australia6 sites

  • Townsville University Hospital

    Douglas, Queensland, 4814

  • Epworth Freemasons

    East Melbourne, Victoria, 3002

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Epworth Hospital

    Richmond, Victoria, 3121

  • Slade Pharmacy

    Richmond, Victoria, 3121

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

Canada3 sites

  • Dr. Everett Chalmers Regional Hospital

    Fredericton, New Brunswick, E3B 5N5

  • CIUSSS de l'Est-de-l'Île-de-Montréal

    Montreal, Quebec, H1T 2M4

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

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: 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.

Read more

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.

Being tested
Elranatamab, Iberdomide
Keywords
elranatamab, PF-06863135, iberdomide, relapsed, refractory, RRMM, BCMA, MagnetisMM, Bispecific antibody, CC-220
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElranatamabDrug

    Also called PF-06863135

    BCMA-CD3 bispecific antibody

  • IberdomideDrug

    Also called CC-220, BMS-986382

    cereblon-modulating agent

Study groups in NCT06215118
Study groupRoleWhat they receive
Part 1 Dose EscalationExperimentalNon-randomized elranatamab plus iberdomide
Receives: Drug: Elranatamab; Drug: Iberdomide
Part 2 Dose RandomizationExperimentalRandomized elranatamab plus iberdomide
Receives: Drug: Elranatamab; Drug: Iberdomide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Dose limiting toxicity rate based on dose limiting toxicity evaluable participants

    Measured: Cycle 1, about 28 days

  2. 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.

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

Secondary outcomes (14)

  1. 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.

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

  2. 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

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

  3. 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

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

  4. 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

    Measured: Assessed for approximately 2 years

  5. 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

    Measured: Assessed for approximately 2 years

  6. 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

    Measured: Assessed for approximately 2 years

  7. 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

    Measured: Assessed for approximately 2 years

  8. 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

    Measured: Assessed for approximately 2 years

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

    Progression free survival (IMWG criteria)

    Measured: Assessed for approximately 2 years

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

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

    Measured: Assessed for approximately 2 years

  11. 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.

    Measured: Assessed for approximately 2 years

  12. Part 1 and Part 2: Concentrations of elranatamab

    Pre-dose and post-dose concentrations of elranatamab

    Measured: Assessed for approximately 2 years

  13. Part 1 and Part 2: Concentrations of iberdomide

    Pre-dose concentrations of iberdomide

    Measured: Assessed for approximately 4 months

  14. 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

    Measured: Assessed for approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start20 Feb 2024
  3. Primary completion16 Nov 2027 (estimated)
  4. Study completion15 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06215118
Sponsor's protocol ID
C1071030
Other IDs
MagnetisMM-30
Status last verified
Sep 2026
First submitted
10 Jan 2024
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Elranatamab and Iberdomide in people with Multiple Myeloma, run by Pfizer at 43 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of participants with dose limiting toxicity (DLT) (time frame: Cycle 1, about 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06215118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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