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 |
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Recruitment Status :
Recruiting
First Posted : October 25, 2021
Last Update Posted : March 20, 2023
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
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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 |
| 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 : | April 20, 2024 |
| Estimated Study Completion Date : | August 17, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Lenalidomide
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sub-Study A
BCMA-CD3 bispecific antibody + gamma secretase inhibitor
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Drug: Elranatamab + Nirogacestat
BCMA-CD3 bispecific antibody + gamma secretase inhibitor
Other Name: PF-06863135 |
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Experimental: Sub-Study B
BCMA-CD3 bispecific antibody + immunomodulatory drug
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Drug: Elranatamab + lenalidomide + dexamethasone
BCMA-CD3 bispecific antibody + immunomodulatory
Other Name: PF-06863135; Revlimid |
Primary Outcome Measures :
- Sub-Study A Phase 1: Dose Limiting Toxicity [ Time Frame: 35 days ]Number of participants with Dose Limiting Toxicity
- Sub-Study A Phase 2: Objective Response Rate [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]Objective response rate (IMWG response criteria)
- Sub-Study B Phase 1 Escalation: Dose Limiting Toxicity [ Time Frame: 42 days ]Number of participants with Dose Limiting Toxicity
- 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)
- 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 :
- Sub-Study A Phase 1: Objective Response Rate [ Time Frame: assessed every 4 weeks (for approximately 2 years) ]Objective response rate (IMWG response criteria)
- 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)
- 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)
- 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)
- 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)
- 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)
- Sub-Study A Phase 1 and Phase 2: Overall Survival [ Time Frame: assessed for approximately 2 years ]Overall survival
- 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)
- 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)
- 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
- 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
- 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
- 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
- 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
- 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
- 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)
- 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
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Sub-Study B Phase 1 Escalation and Expansion: Overall Survival [ Time Frame: assessed for approximately 2 years ]Overall survival
- 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)
- 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
- 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
- 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
- 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
- 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
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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
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Measurable disease defined by at least one 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
- 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
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Locations
Show 34 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| 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 20, 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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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 |