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NCT05090566 Clinical Trial

MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
A PHASE 1B/2, OPEN LABEL UMBRELLA STUDY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, IN COMBINATION WITH OTHER ANTI-CANCER TREATMENTS IN PARTICIPANTS WITH MULTIPLE MYELOMA

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05090566
Other study ID # C1071004
Secondary ID Umbrella StudyMA
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 27, 2021
Est. completion date July 2, 2027

Study information
Verified date April 2024
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date July 2, 2027
Est. primary completion date August 16, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy - Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody - Measurable disease defined by at least one of the following: 1. Serum M-protein >/= 0.5 g/dL by SPEP 2. Urinary M-protein excretion >/= 200 mg/24 hours by UPEP 3. Serum immunoglobulin FLC >/= 10 mg/dL (>/= 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio - ECOG performance status 0 -1 - Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade </= 1 Exclusion Criteria: - Active plasma cell leukemia - Amyloidosis - Stem cell transplant with 12 weeks prior to enrollment, or active GVHD - POEMS syndrome - Any active uncontrolled bacterial, fungal, or viral infection - Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment - Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer) - Sub-Study A Only: Previous treatment with BCMA bispecific antibody - Sub-Study B Only: Previous treatment with BCMA directed therapy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Elranatamab + Nirogacestat
BCMA-CD3 bispecific antibody + gamma secretase inhibitor
• Elranatamab + lenalidomide + dexamethasone
BCMA-CD3 bispecific antibody + immunomodulatory

Locations
Country Name City State
Canada Tom Baker Cancer Center Calgary Alberta
Canada The Ottawa Hospital - General Campus Ottawa Ontario
Canada Princess Margaret Cancer Centre Toronto Ontario
United States OIDS, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Also Imaging Facility) Baltimore Maryland
United States Nebraska Medicine - Bellevue Medical Center Bellevue Nebraska
United States Beverly Hills Cancer Center Beverly Hills California
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States UChicago Medicine - River East Chicago Illinois
United States University of Chicago Medical Center Chicago Illinois
United States Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center Coral Gables Florida
United States Sylvester Comprehensive Cancer Center- Deerfield Beach Deerfield Beach Florida
United States The University of Kansas Cancer Center ,Investigational Drug Services Fairway Kansas
United States The University of Kansas Clinical Research Center Fairway Kansas
United States UChicago Medicine at Ingalls - Flossmoor Flossmoor Illinois
United States Banner Gateway Medical Center Gilbert Arizona
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States UChicago Medicine Ingalls Memorial Harvey Illinois
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States The University of Kansas Hospital Kansas City Kansas
United States The University of Kansas Hospital Investigational Drug Services Kansas City Kansas
United States The University of Kansas Medical Center Medical Office Building Kansas City Kansas
United States University of Kansas Hospital Cambridge North Tower A Kansas City Kansas
United States University of Arkansas for Medical Sciences - Winthrop P. Rockefeller Cancer Institute Little Rock Arkansas
United States Cedars Sinai Medical Center Los Angeles California
United States Cedars Sinai Medical Center Oncology IDS Pharmacy Attn:Suwicha Limvorasak ,PharmaD Los Angeles California
United States Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI) Los Angeles California
United States Sylvester Comprehensive Cancer Center Miami Florida
United States UHealth Tower Miami Florida
United States University of Chicago Comprehensive Cancer Center at Silver Cross Hospital New Lenox Illinois
United States Nebraska Medicine - Cancer Center at Village Pointe Health Center Omaha Nebraska
United States Nebraska Medicine - Nebraska Medical Center Omaha Nebraska
United States University Of Nebraska Medical Center Omaha Nebraska
United States University Of Nebraska Medical Center Omaha Nebraska
United States The University of Chicago Medicine Center for Advanced Care Orland Park Orland Park Illinois
United States The University of Kansas Cancer Center - Indian Creek Campus Overland Park Kansas
United States UChicago Medicine at Ingalls - Tinley Park Tinley Park Illinois
United States The University of Kansas Cancer Center Westwood Kansas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sub-Study A Phase 1: Dose Limiting Toxicity Number of participants with Dose Limiting Toxicity approximately 35 days
Primary Sub-Study A Phase 2: Objective Response Rate Objective response rate (IMWG response criteria) assessed every 4 weeks (for approximately 2 years)
Primary Sub-Study B Phase 1 Escalation: Dose Limiting Toxicity Number of participants with Dose Limiting Toxicity approximately 42 days
Secondary Sub-Study A Phase 1: Objective Response Rate Objective response rate (IMWG response criteria) assessed every 4 weeks (for approximately 2 years)
Secondary Sub-Study A Phase 1 and Phase 2: Complete Response Rate Complete response rate (IMWG response criteria) assessed every 4 weeks (for approximately 2 years)
Secondary Sub-Study A Phase 1 and Phase 2: Time to Response Time to response (IMWG criteria) assessed every 4 weeks (for approximately 2 years)
Secondary Sub-Study A Phase 1 and 2: Duration of Response Duration of response (IMWG response criteria) assessed every 4 weeks (for approximately 2 years)
Secondary Sub-Study A Phase 1 and Phase 2: Duration of Complete Response Duration of complete response (IMWG response criteria) assessed every 4 weeks (for approximately 2 years)
Secondary Sub-Study A Phase 1 and Phase 2: Progression Free Survival Progression free survival (IMWG response criteria) assessed every 4 weeks (for approximately 2 years)
Secondary Sub-Study A Phase 1 and Phase 2: Overall Survival Overall survival assessed for approximately 2 years
Secondary Sub-Study A Phase 1 and Phase 2: Minimal Residual Disease Negativity Rate Minimal residual disease negativity rate (IMWG response criteria) assessed approximately every 12 months (for approximately 2 years)
Secondary Sub-Study A Phase 1 and Phase 2: Frequency of Treatment-Emergent Adverse Events Type and severity per NCI CTCAE v5 (CRS and ICANS assessed per ASTCT criteria) assessed for approximately 2 years
Secondary Sub-Study A Phase 1 and Phase 2: Frequency of Laboratory Abnormalities Type and severity per NCI CTCAE v5 assessed every cycle (each cycle approximately 28 days)
Secondary Sub-Study A Phase 1 and Phase 2: Immunogenicity of elranatamab in combination with nirogacestat Anti-drug antibodies and neutralizing antibodies against elranatamab assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)
Secondary Sub-Study A Phase 1 and Phase 2: Concentrations of elranatamab and/or nirogacestat Pre-dose and post-dose concentrations of elranatamab; pre-dose concentrations of nirogacestat assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)
Secondary Sub-Study A Phase 1: Maximum Observed Concentration (Cmax) for elranatamab Cmax for elranatamab administration assessed after first elranatamab dose (approximately 3-7 days)
Secondary Sub-Study A Phase 1: Time to Maximum Concentration (Tmax) for elranatamab Tmax for elranatamab administration assessed after first elranatamab dose (approximately 3-7 days)
Secondary Sub-Study A Phase 1: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab AUClast for elranatamab administration assessed after first elranatamab dose (approximately 3-7 days)
Secondary Sub-Study B Phase 1 Escalation: Frequency of Treatment-Emergent Adverse Events Type and severity per NCI CTCAE v5 (CRS and ICANS assessed per ASTCT criteria) assessed for approximately 2 years
Secondary Sub-Study B Phase 1 Escalation: Frequency of Laboratory Abnormalities Type and severity per NCI CTCAE v5 assessed every cycle (each cycle approximately 28 days)
Secondary Sub-Study B Phase 1 Escalation: Objective Response Rate Objective response rate (IMWG response criteria) assessed every 4 weeks (for approximately 2 years)
Secondary Sub-Study B Phase 1 Escalation: Complete Response Rate Complete response rate (IMWG response criteria) assessed every 4 weeks (for approximately 2 years)
Secondary Sub-Study B Phase 1 Escalation: Time to Response Time to response (IMWG criteria) assessed every 4 weeks (for approximately 2 years)
Secondary Sub-Study B Phase 1 Escalation: Duration of Response Duration of response (IMWG response criteria) assessed every 4 weeks (for approximately 2 years)
Secondary Sub-Study B Phase 1 Escalation: Duration of Complete Response Duration of complete response (IMWG response criteria) assessed every 4 weeks (for approximately 2 years)
Secondary Sub-Study B Phase 1 Escalation: Progression Free Survival Progression free survival (IMWG response criteria) assessed every 4 weeks (for approximately 2 years)
Secondary Sub-Study B Phase 1 Escalation: Overall Survival Overall survival assessed for approximately 2 years
Secondary Sub-Study B Phase 1 Escalation: Minimal Residual Disease Negativity Rate Minimal residual disease negativity ratio (IMWG response criteria) assessed approximately every 12 months (for approximately 2 years)
Secondary Sub-Study B Phase 1 Escalation: Immunogenicity of elranatamab in combination with lenalidomide Anti-drug antibodies and neutralizing antibodies against elranatamab assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)
Secondary Sub-Study B Phase 1 Escalation: Concentrations of elranatamab and/or lenalidomide Pre-dose and post-dose concentrations of elranatamab, pre-dose concentrations of lenalidomide assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)
Secondary Sub-Study B Phase 1 Escalation: Maximum Observed Concentrations (Cmax) for elranatamab Cmax for elranatamab administration assessed after first elranatamab dose (approximately 3-7 days)
Secondary Sub-Study B Phase 1 Escalation: Time to Maximum Concentration (Tmax) for elranatamab Tmax for elranatamab administration assessed after first elranatamab dose (approximately 3-7 days)
Secondary Sub-Study B Phase 1 Escalation: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab AUClast for elranatamab administration assessed after first elranatamab dose (approximately 3-7 days)
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Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
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Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
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