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A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment (MagnetisMM-9)

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ClinicalTrials.gov Identifier: NCT05014412
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:

The purpose of this study is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses.

Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Elranatamab Phase 2

Detailed Description:
The purpose of this study is to evaluate the safety (in particular the rate of Grade ≥ 2 CRS) of a step-up priming dose regimen of elranatamab in participants with relapsed/refractory multiple myeloma. In addition, this study will assess the safety of different dosing regimens of elranatamab and if it can provide a clinical benefit in those participants. Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE A DOSING REGIMEN WITH TWO STEP-UP PRIMING DOSES AND LONGER DOSING INTERVALS OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
Actual Study Start Date : October 7, 2021
Estimated Primary Completion Date : June 27, 2023
Estimated Study Completion Date : April 3, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Part 1
Evaluation of step-up priming dosing
Drug: Elranatamab
BCMA-CD3 bispecific antibody

Experimental: Part 2A
Dose determination
Drug: Elranatamab
BCMA-CD3 bispecific antibody

Experimental: Part 2B
Dose expansion
Drug: Elranatamab
BCMA-CD3 bispecific antibody

Experimental: Part 2C
To explore higher dose intensity
Drug: Elranatamab
BCMA-CD3 bispecific antibody




Primary Outcome Measures :
  1. Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) [ Time Frame: Cycle 1 (28 days) ]
    Cytokine release syndrome severity assessed by American Society for Transplantation and Cellular Therapy (ASTCT) criteria


Secondary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities (Part 2A only) [ Time Frame: Cycle 2 (28 days) ]
  2. Frequency of Adverse Events [ Time Frame: Up to 90 days after last dose and for approximately 2 years ]
    Adverse Events as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, timing, seriousness, and relationship to elranatamab

  3. Frequency of laboratory abnormalities [ Time Frame: Assessed at every cycles [each cycle approximately 28 days] ]
  4. Objective response rate [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]
    Objective response rate per International Myeloma Working Group (IMWG) response criteria

  5. Cumulative Complete Response Rate [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]
    Cumulative Complete Response Rate per IMWG response criteria

  6. Time to response [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]
    Time to response per IMWG response criteria

  7. Duration of response [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]
    Duration of response per IMWG response criteria

  8. Duration of cumulative complete response rate [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]
    Duration of cumulative complete response rate per IMWG response criteria

  9. Progression Free Survival [ Time Frame: Assessed approximately every 28 days for approximately 2 years ]
  10. Overall Survival [ Time Frame: Approximately 2 years ]
  11. Minimal Residual Disease negativity rate [ Time Frame: Assessed approximately every 12 months and for approximately 2 years ]
    Minimal Residual Disease negativity rate assessed by central lab per IMWG sequencing criteria

  12. Pre- and postdose concentrations of elranatamab [ Time Frame: Assessed approximately every 1 to 3 cycles [cycle of approximately 28 days] ]
    Pharmacokinetic of elranatamab

  13. Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab [ Time Frame: Assessed approximately every 1 to 6 cycles [cycle of approximately 28 days] ]
    Immunogenicity of elranatamab



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:

  • Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
  • Measurable disease, as defined by at least 1 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
  • Refractory to at least one IMiD
  • Refractory to at least one PI
  • Refractory to at least one anti-CD38 antibody
  • Relapsed/refractory to last anti-myeloma regimen
  • ECOG performance status ≤1
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
  • Not pregnant and willing to use contraception

Exclusion Criteria:

  • Smoldering multiple myeloma
  • Active Plasma cell leukemia
  • POEMS syndrome
  • Amyloidosis
  • Stem cell transplant within 12 weeks prior to enrollment or active GVHD
  • Active HBV, HCV, SARS-CoV2, HIV, or 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 an anti-BCMA bispecific antibody.
  • Live attenuated vaccine within 4 weeks of the first dose
  • Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

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): NCT05014412


Contacts
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Contact: Pfizer CT.gov Call Center, Please reference C1071009 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 30 study locations
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: NCT05014412    
Other Study ID Numbers: C1071009
MagnetisMM-9 ( Other Identifier: Alias Study Number )
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 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:
BCMA
Multiple Myeloma
Relapse/Refractory
RRMM
Elranatamab
Targeted T-cell
MagnetisMM
MM9
Phase 2
B-Cell Maturation Antigen
monoclonal antibody
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