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 — Phase 1, Active not recruiting, 100 participants, Pfizer

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

RegistryNCT06215118
StatusActive not recruiting
PhasePhase 1
Study typeInterventional; randomized, sequential, masking: none, treatment
Enrollment100 (Actual)
SponsorPfizer (Industry); collaborators: Bristol-Myers Squibb
ConditionsMultiple Myeloma
InterventionsElranatamab, Iberdomide (Drug)
Datesstart 2024-02-20, primary completion 2027-11-16 (estimated), completion 2028-10-15 (estimated), first posted 2024-01-22, last updated 2026-09-15
Locations43 sites in United States, Australia, Canada

Related Papers Related Patents Related Grants Related Experts
All trials for Multiple Myeloma All trials of Elranatamab All trials of Iberdomide

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Part 1 Dose EscalationExperimentalDrug: Elranatamab; Drug: IberdomideNon-randomized elranatamab plus iberdomide
Part 2 Dose RandomizationExperimentalDrug: Elranatamab; Drug: IberdomideRandomized elranatamab plus iberdomide
  • Elranatamab (Drug), also known as PF-06863135: BCMA-CD3 bispecific antibody
  • Iberdomide (Drug), also known as CC-220, BMS-986382: cereblon-modulating agent

+Outcome measures

Primary outcomes

  • Part 1: Number of participants with dose limiting toxicity (DLT) [Cycle 1, about 28 days]: Dose limiting toxicity rate based on dose limiting toxicity evaluable participants
  • Part 2: 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]: 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

  • 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]: 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.
  • 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]: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibly of causal relationship
  • 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]: Laboratory abnormalities as characterized by type, frequency, severity
  • Part 1 and Part 2: Percentage of Participants with Objective Response Rate (ORR) [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
  • Part 1 and Part 2: Percentage of Participants with Complete Response Rate (CRR) [Assessed for approximately 2 years]: Percent of participants having Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria as determined by investigator
  • Part 1 and Part 2: Time to Response (TTR) [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
  • Part 1 and Part 2: Duration of Response (DOR) [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
  • Part 1 and Part 2: Duration of Complete Response (DOCR) [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
  • Part 1 and Part 2: Time of Progression Free Survival (PFS) [Assessed for approximately 2 years]: Progression free survival (IMWG criteria)
  • Part 1 and Part 2: Time of Overall Survival (OS) [Assessed for approximately 2 years]: The duration of time from first dose of study treatment to death
  • Part 1 and Part 2: Minimal Residual Disease (MRD) Negativity Rate [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.
  • Part 1 and Part 2: Concentrations of elranatamab [Assessed for approximately 2 years]: Pre-dose and post-dose concentrations of elranatamab
  • Part 1 and Part 2: Concentrations of iberdomide [Assessed for approximately 4 months]: Pre-dose concentrations of iberdomide
  • Part 1 and Part 2: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab [Assessed for approximately 2 years]: Percent of participants with positive ADA to elranatamab when given in combination with iberdomide

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (43)

FacilityCityCountryStatus
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical CenterCoral Gables, FloridaUnited States
University of Miami Hospital and Clinics Deerfield BeachDeerfield Beach, FloridaUnited States
Sylvester Comprehensive Cancer Center- DoralDoral, FloridaUnited States
Sylvester Comprehensive Cancer CenterMiami, FloridaUnited States
University of Miami Hospital and ClinicsMiami, FloridaUnited States
Sylvester Comprehensive Cancer Center KendallMiami, FloridaUnited States
Sylvester Comprehensive Cancer Center PlantationPlantation, FloridaUnited States
Emory University Hospital MidtownAtlanta, GeorgiaUnited States
Emory University HospitalAtlanta, GeorgiaUnited States
Winship Cancer InstituteAtlanta, GeorgiaUnited States
Indiana CTSI Clinical Research Center (ICRC)Indianapolis, IndianaUnited States
Indiana University Health University HospitalIndianapolis, IndianaUnited States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC)Indianapolis, IndianaUnited States
University of MarylandBaltimore, MarylandUnited States
Brigham and Women's HospitalBoston, MassachusettsUnited States
Dana-Farber Cancer InstituteBoston, MassachusettsUnited States
Dana-Farber Cancer Institute - Chestnut HillNewton, MassachusettsUnited States
University of Massachusetts Chan Medical SchoolWorcester, MassachusettsUnited States
Methodist HospitalOmaha, NebraskaUnited States
Oncology Hematology West P.C. dba Nebraska Cancer - MethodistOmaha, NebraskaUnited States
Oncology Hematology West P.C. dba Nebraska Cancer SpecialistsOmaha, NebraskaUnited States
Dartmouth Hitchcock Medical CenterLebanon, New HampshireUnited States
MSK Basking RidgeBasking Ridge, New JerseyUnited States
MSK MonmouthMiddletown, New JerseyUnited States
MSK BergenMontvale, New JerseyUnited States
MSK CommackCommack, New YorkUnited States
MSK WestchesterHarrison, New YorkUnited States
Memorial Sloan Kettering Cancer Center - Investigational Drug Service PharmacyLong Island City, New YorkUnited States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).New York, New YorkUnited States
Memorial Sloan Kettering Cancer Center - Main CampusNew York, New YorkUnited States
MSK NassauUniondale, New YorkUnited States
Fred Hutchinson Cancer CenterSeattle, WashingtonUnited States
University of WashingtonSeattle, WashingtonUnited States
Medical College of WisconsinMilwaukee, WisconsinUnited States
Liverpool HospitalLiverpool, New South WalesAustralia
Calvary Mater NewcastleWaratah, New South WalesAustralia
Townsville University HospitalDouglas, QueenslandAustralia
Epworth FreemasonsEast Melbourne, VictoriaAustralia
Epworth HospitalRichmond, VictoriaAustralia
Slade PharmacyRichmond, VictoriaAustralia
Dr. Everett Chalmers Regional HospitalFredericton, New BrunswickCanada
CIUSSS de l'Est-de-l'Île-de-MontréalMontreal, QuebecCanada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier UniverSherbrooke, QuebecCanada

+Investigators

  • Pfizer CT.gov Call Center, Study director, Pfizer