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

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ClinicalTrials.gov Identifier: NCT05090566
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Elranatamab + Nirogacestat Drug: Elranatamab + lenalidomide + dexamethasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 27, 2021
Estimated Primary Completion Date : November 24, 2025
Estimated Study Completion Date : August 17, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Sub-Study A
BCMA-CD3 bispecific antibody + gamma secretase inhibitor
Drug: Elranatamab + Nirogacestat
BCMA-CD3 bispecific antibody + gamma secretase inhibitor
Other Name: PF-06863135

Experimental: Sub-Study B
BCMA-CD3 bispecific antibody + immunomodulatory drug
Drug: Elranatamab + lenalidomide + dexamethasone
BCMA-CD3 bispecific antibody + immunomodulatory
Other Name: PF-06863135; Revlimid




Primary Outcome Measures :
  1. Sub-Study A Phase 1: Dose Limiting Toxicity [ Time Frame: 35 days ]
    Number of participants with Dose Limiting Toxicity

  2. Sub-Study A Phase 2: Objective Response Rate [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]
    Objective response rate (IMWG response criteria)

  3. Sub-Study B Phase 1 Escalation: Dose Limiting Toxicity [ Time Frame: 42 days ]
    Number of participants with Dose Limiting Toxicity

  4. Sub-Study B Phase 1 Expansion: Frequency of Treatment-Emergent Adverse Events [ Time Frame: assessed for approximately 2 years ]
    Type and severity per NCI CTCAE v5 (CRS and ICANS assessed per ASTCT criteria)

  5. Sub-Study B Phase 1 Expansion: Frequency of Laboratory Abnormalities [ Time Frame: assessed every cycle (each cycle approximately 28 days) ]
    Type and severity per NCI CTCAE v5


Secondary Outcome Measures :
  1. Sub-Study A Phase 1: Objective Response Rate [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]
    Objective response rate (IMWG response criteria)

  2. Sub-Study A Phase 1 and Phase 2: Complete Response Rate [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]
    Complete response rate (IMWG response criteria)

  3. Sub-Study A Phase 1 and Phase 2: Time to Response [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]
    Time to response (IMWG criteria)

  4. Sub-Study A Phase 1 and 2: Duration of Response [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]
    Duration of response (IMWG response criteria)

  5. Sub-Study A Phase 1 and Phase 2: Duration of Complete Response [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]
    Duration of complete response (IMWG response criteria)

  6. Sub-Study A Phase 1 and Phase 2: Progression Free Survival [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]
    Progression free survival (IMWG response criteria)

  7. Sub-Study A Phase 1 and Phase 2: Overall Survival [ Time Frame: assessed for approximately 2 years ]
    Overall survival

  8. Sub-Study A Phase 1 and Phase 2: Minimal Residual Disease Negativity Rate [ Time Frame: assessed approximately every 12 months (for approximately 2 years) ]
    Minimal residual disease negativity rate (IMWG response criteria)

  9. Sub-Study A Phase 1 and Phase 2: Frequency of Treatment-Emergent Adverse Events [ Time Frame: assessed for approximately 2 years ]
    Type and severity per NCI CTCAE v5 (CRS and ICANS assessed per ASTCT criteria)

  10. Sub-Study A Phase 1 and Phase 2: Frequency of Laboratory Abnormalities [ Time Frame: assessed every cycle (each cycle approximately 28 days) ]
    Type and severity per NCI CTCAE v5

  11. Sub-Study A Phase 1 and Phase 2: Immunogenicity of elranatamab in combination with nirogacestat [ Time Frame: assessed approximately every 1 to 3 cycles (each cycle approximately 28 days) ]
    Anti-drug antibodies and neutralizing antibodies against elranatamab

  12. Sub-Study A Phase 1 and Phase 2: Concentrations of elranatamab and/or nirogacestat [ Time Frame: assessed approximately every 1 to 3 cycles (each cycle approximately 28 days) ]
    Pre-dose and post-dose concentrations of elranatamab; pre-dose concentrations of nirogacestat

  13. Sub-Study A Phase 1: Maximum Observed Concentration (Cmax) for elranatamab [ Time Frame: assessed after first elranatamab dose (approximately 3-7 days) ]
    Cmax for elranatamab administration

  14. Sub-Study A Phase 1: Time to Maximum Concentration (Tmax) for elranatamab [ Time Frame: assessed after first elranatamab dose (approximately 3-7 days) ]
    Tmax for elranatamab administration

  15. Sub-Study A Phase 1: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab [ Time Frame: assessed after first elranatamab dose (approximately 3-7 days) ]
    AUClast for elranatamab administration

  16. Sub-Study B Phase 1 Escalation: Frequency of Treatment-Emergent Adverse Events [ Time Frame: assessed for approximately 2 years ]
    Type and severity per NCI CTCAE v5 (CRS and ICANS assessed per ASTCT criteria)

  17. Sub-Study B Phase 1 Escalation: Frequency of Laboratory Abnormalities [ Time Frame: assessed every cycle (each cycle approximately 28 days) ]
    Type and severity per NCI CTCAE v5

  18. Sub-Study B Phase 1 Escalation and Expansion: Objective Response Rate [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]
    Objective response rate (IMWG response criteria)

  19. Sub-Study B Phase 1 Escalation and Expansion: Complete Response Rate [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]
    Complete response rate (IMWG response criteria)

  20. Sub-Study B Phase 1 Escalation and Expansion: Time to Response [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]
    Time to response (IMWG criteria)

  21. Sub-Study B Phase 1 Escalation and Expansion: Duration of Response [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]
    Duration of response (IMWG response criteria)

  22. Sub-Study B Phase 1 Escalation and Expansion: Duration of Complete Response [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]
    Duration of complete response (IMWG response criteria)

  23. Sub-Study B Phase 1 Escalation and Expansion: Progression Free Survival [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]
    Progression free survival (IMWG response criteria)

  24. Sub-Study B Phase 1 Escalation and Expansion: Overall Survival [ Time Frame: assessed for approximately 2 years ]
    Overall survival

  25. Sub-Study B Phase 1 Escalation and Expansion: Minimal Residual Disease Negativity Rate [ Time Frame: assessed approximately every 12 months (for approximately 2 years) ]
    Minimal residual disease negativity ratio (IMWG response criteria)

  26. Sub-Study B Phase 1 Escalation and Expansion: Immunogenicity of elranatamab in combination with lenalidomide [ Time Frame: assessed approximately every 1 to 3 cycles (each cycle approximately 28 days) ]
    Anti-drug antibodies and neutralizing antibodies against elranatamab

  27. Sub-Study B Phase 1 Escalation and Expansion: Concentrations of elranatamab and/or lenalidomide [ Time Frame: assessed approximately every 1 to 3 cycles (each cycle approximately 28 days) ]
    Pre-dose and post-dose concentrations of elranatamab, pre-dose concentrations of lenalidomide

  28. Sub-Study B Phase 1 Escalation and Expansion: Maximum Observed Concentrations (Cmax) for elranatamab [ Time Frame: assessed after first elranatamab dose (approximately 3-7 days) ]
    Cmax for elranatamab administration

  29. Sub-Study B Phase 1 Escalation and Expansion: Time to Maximum Concentration (Tmax) for elranatamab [ Time Frame: assessed after first elranatamab dose (approximately 3-7 days) ]
    Tmax for elranatamab administration

  30. Sub-Study B Phase 1 Escalation and Expansion: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab [ Time Frame: assessed after first elranatamab dose (approximately 3-7 days) ]
    AUClast for elranatamab administration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05090566


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, Florida
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center Recruiting
Coral Gables, Florida, United States, 33146
Sylvester Comprehensive Cancer Center- Deerfield Beach Recruiting
Deerfield Beach, Florida, United States, 33442
Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
UHealth Tower Recruiting
Miami, Florida, United States, 33136
United States, Illinois
UChicago Medicine - River East Not yet recruiting
Chicago, Illinois, United States, 60611
University of Chicago Medical Center Not yet recruiting
Chicago, Illinois, United States, 60637
UChicago Medicine at Ingalls - Flossmoor Not yet recruiting
Flossmoor, Illinois, United States, 60422
UChicago Medicine Ingalls Memorial Not yet recruiting
Harvey, Illinois, United States, 60426
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital Not yet recruiting
New Lenox, Illinois, United States, 60451
The University of Chicago Medicine Center for Advanced Care Orland Park Not yet recruiting
Orland Park, Illinois, United States, 60462
UChicago Medicine at Ingalls - Tinley Park Not yet recruiting
Tinley Park, Illinois, United States, 60477
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05090566    
Other Study ID Numbers: C1071004
Umbrella Study ( Other Identifier: Alias Study Number )
MAGNETISMM-4 ( Other Identifier: Alias Study Number )
2021-003885-11 ( EudraCT Number )
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
PF-06863135, Multiple Myeloma, BCMA, elranatamab, bispecific antibody, MagnetisMM-4
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Lenalidomide
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents