A Study to Learn About the Study Medicine (Elranatamab) Either Alone or in Combination With Dexamethasone 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 |
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Recruitment Status :
Recruiting
First Posted : August 20, 2021
Last Update Posted : March 9, 2023
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Brief Summary:
The purpose of Part 1 and Part 2 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). The purpose of Part 3 of the study is to evaluate the safety and efficacy of elranatamab in combination with dexamethasone during the first 6 cycles followed by elranatamab monotherapy. 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 Drug: Elranatamab+ dexamethasone | Phase 2 |
The purpose of Part 1 and Part 2 of the 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. The purpose of Part 3 is to evaluate the safety and efficacy of elranatamab in combination with dexamethasone during the first 6 cycles followed by elranatamab monotherapy. 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.
| 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 : | August 14, 2024 |
| Estimated Study Completion Date : | May 16, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part 1
Evaluation of step-up priming dosing
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Drug: Elranatamab
BCMA-CD3 bispecific antibody |
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Experimental: Part 2A
Dose determination
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Drug: Elranatamab
BCMA-CD3 bispecific antibody |
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Experimental: Part 2B
Dose expansion
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Drug: Elranatamab
BCMA-CD3 bispecific antibody |
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Experimental: Part 2C
To explore higher dose intensity
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Drug: Elranatamab
BCMA-CD3 bispecific antibody |
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Experimental: Part 3
To explore the combination with dexamethasone
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Drug: Elranatamab+ dexamethasone
BCMA-CD3 bispecific antibody + corticosteroids (dexamethasone) |
Primary Outcome Measures :
- Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) (Part 1 and 2) [ Time Frame: Cycle 1 (28 days) ]Cytokine release syndrome severity assessed by American Society for Transplantation and Cellular Therapy (ASTCT) criteria
- Number of participants with overall response rate (ORR) per International Myeloma Working Group (IMWG) criteria (Part 3). [ Time Frame: From the date of first dose until the first documentation of progressive disease (PD), death or start of new anticancer therapy, whichever occurs first (timeframe: approximately 2 years). ]Treatment effect of elranatamab + dexamethasone on ORR per IMWG criteria.
Secondary Outcome Measures :
- Incidence of Dose Limiting Toxicities (Part 2A and 2C) [ Time Frame: 28 days starting on the first dose of 116 or 152 mg ]
- 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
- Frequency of laboratory abnormalities [ Time Frame: Assessed at every cycles [each cycle approximately 28 days] ]
- 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
- Complete Response Rate [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]Complete Response Rate per IMWG response criteria
- Time to response [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]Time to response per IMWG response criteria
- Duration of response [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]Duration of response per IMWG response criteria
- Duration of complete response rate [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]Duration of complete response rate per IMWG response criteria
- Progression Free Survival [ Time Frame: Assessed approximately every 28 days for approximately 2 years ]
- Overall Survival [ Time Frame: Approximately 2 years ]
- 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
- Pre- and postdose concentrations of elranatamab [ Time Frame: Assessed approximately every 1 to 3 cycles [cycle of approximately 28 days] ]Pharmacokinetic of elranatamab
- 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
- Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) (Part 3) [ Time Frame: Cycle 1 (28 days) ]Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) when elranatamab is administered in combination with dexamethasone (Part 3)
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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)
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Measurable disease, 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 hours by UPEP
- 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
- Waldenström's macroglobulinemia
- Known active CNS involvement or clinical signs of myelomatous meningeal involvement
- 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 or Stage 0/1 malignancy with minimal risk of recurrence per investigator.
- Previous treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy.
- 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)
- Known or suspected hypersensitivity to the study intervention, or any of its excipients or unable to tolerate systemic corticosteroids at doses planned to be administered in the study Part 3
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
| Contact: Pfizer CT.gov Call Center, Please reference C1071009 | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Locations
Show 39 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| 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: | March 9, 2023 |
| Last Verified: | March 2023 |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Pfizer:
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BCMA Multiple Myeloma Relapse/Refractory RRMM Elranatamab Dexamethasone |
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 Dexamethasone 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 |