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)

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215118
• Other study ID #: C1071030
• Secondary ID: MagnetisMM-30
• Status: Recruiting
• Phase: Phase 1
• Start date: February 20, 2024
• Est. completion date: March 9, 2028

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 9, 2028
• Est. primary completion date: April 10, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Elranatamab
BCMA-CD3 bispecific antibody
• Iberdomide
cereblon-modulating agent

Locations

Country	Name	City	State
Canada	Dr. Everett Chalmers Regional Hospital	Fredericton	New Brunswick
United States	MSK Basking Ridge	Basking Ridge	New Jersey
United States	MSK Commack	Commack	New York
United States	MSK Westchester	Harrison	New York
United States	Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy	Long Island City	New York
United States	MSK Monmouth	Middletown	New Jersey
United States	MSK Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).	New York	New York
United States	Memorial Sloan Kettering Cancer Center - Main Campus	New York	New York
United States	MSK Nassau	Uniondale	New York

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Assessed from baseline up to 90 days after last dose of study treatment
Secondary	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	Assessed from baseline up to 90 days after last dose of study treatment
Secondary	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	Assessed from baseline up to 90 days after last dose of study treatment
Secondary	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	Assessed for approximately 2 years
Secondary	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	Assessed for approximately 2 years
Secondary	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	Assessed for approximately 2 years
Secondary	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	Assessed for approximately 2 years
Secondary	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	Assessed for approximately 2 years
Secondary	Part 1 and Part 2: Time of Progression Free Survival (PFS)	Progression free survival (IMWG criteria)	Assessed for approximately 2 years
Secondary	Part 1 and Part 2: Time of Overall Survival (OS)	The duration of time from first dose of study treatment to death	Assessed for approximately 2 years
Secondary	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.	Assessed for approximately 2 years
Secondary	Part 1 and Part 2: Concentrations of elranatamab	Pre-dose and post-dose concentrations of elranatamab	Assessed for approximately 2 years
Secondary	Part 1 and Part 2: Concentrations of iberdomide	Pre-dose concentrations of iberdomide	Assessed for approximately 4 months
Secondary	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	Assessed for approximately 2 years

External Links

•   MagnetisMM-30 Enrolling people with Multiple Myeloma, click here
•   To obtain contact information for a study center near you, click here.