Clinical trial 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)
Official title: A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH IBERDOMIDE IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: elranatamab
PF-06863135
iberdomide
relapsed
refractory
RRMM
BCMA
MagnetisMM
Bispecific antibody
CC-220
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2024-01-22
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Part 1: Number of participants with dose limiting toxicity (DLT)
timeFrame: Cycle 1, about 28 days
measure: Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment
timeFrame: Assessed from baseline up to 90 days after last dose of study treatment
Secondary outcomes:
measure: Part 1: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment
timeFrame: Assessed from baseline up to 90 days after last dose of study treatment
measure: Part 1 and Part 2: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity
timeFrame: Assessed from baseline up to 90 days after last dose of study treatment
measure: Part 1 and Part 2: Number of Participants with Clinically Significant Change from Baseline in Laboratory Abnormalities
timeFrame: Assessed from baseline up to 90 days after last dose of study treatment
measure: Part 1 and Part 2: Percentage of Participants with Objective Response Rate (ORR)
timeFrame: Assessed for approximately 2 years
measure: Part 1 and Part 2: Percentage of Participants with Complete Response Rate (CRR)
timeFrame: Assessed for approximately 2 years
measure: Part 1 and Part 2: Time to Response (TTR)
timeFrame: Assessed for approximately 2 years
measure: Part 1 and Part 2: Duration of Response (DOR)
timeFrame: Assessed for approximately 2 years
measure: Part 1 and Part 2: Duration of Complete Response (DOCR)
timeFrame: Assessed for approximately 2 years
measure: Part 1 and Part 2: Time of Progression Free Survival (PFS)
timeFrame: Assessed for approximately 2 years
measure: Part 1 and Part 2: Time of Overall Survival (OS)
timeFrame: Assessed for approximately 2 years
measure: Part 1 and Part 2: Minimal Residual Disease (MRD) Negativity Rate
timeFrame: Assessed for approximately 2 years
measure: Part 1 and Part 2: Concentrations of elranatamab
timeFrame: Assessed for approximately 2 years
measure: Part 1 and Part 2: Concentrations of iberdomide
timeFrame: Assessed for approximately 4 months
measure: Part 1 and Part 2: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab
timeFrame: Assessed for approximately 2 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Indianapolis
country: United States
facility: Indiana CTSI Clinical Research Center (ICRC)
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC)
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Newton
country: United States
facility: Dana-Farber Cancer Institute - Chestnut Hill
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Omaha
country: United States
facility: Methodist Hospital
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West P.C. dba Nebraska Cancer - Methodist
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialists
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Basking Ridge
country: United States
facility: MSK Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: MSK Monmouth
state: New Jersey
city: Montvale
country: United States
facility: MSK Bergen
state: New Jersey
city: Commack
country: United States
facility: MSK Commack
state: New York
city: Harrison
country: United States
facility: MSK Westchester
state: New York
city: Long Island City
country: United States
facility: Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center - Main Campus
state: New York
city: Uniondale
country: United States
facility: MSK Nassau
state: New York
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Douglas
country: Australia
facility: Townsville University Hospital
state: Queensland
city: East Melbourne
country: Australia
facility: Epworth Freemasons
state: Victoria
city: Richmond
country: Australia
facility: Epworth Hospital
state: Victoria
city: Richmond
country: Australia
facility: Slade Pharmacy
state: Victoria
city: Fredericton
country: Canada
facility: Dr. Everett Chalmers Regional Hospital
state: New Brunswick
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: