A Clinical Trial of Three Medicines (Elranatamab Plus Carfilzomib and Dexamethasone) in People With Relapsed Refractory Multiple Myeloma (MagnetisMM-20)
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|ClinicalTrials.gov Identifier: NCT05675449|
Recruitment Status : Recruiting
First Posted : January 9, 2023
Last Update Posted : March 17, 2023
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The purpose of this study is to understand the effects of elranatamab plus carfilzomib and dexamethasone for the treatment of people with multiple myeloma. Multiple myeloma is a form of cancer in the bone that forces healthy blood cells out. The investigators are seeking people who:
- Are male and female with multiple myeloma.
- Have received at least 1 but no more than 3 lines of therapy for multiple myeloma.
- Are 18 years of age or older.
- A female participant is eligible if she is not pregnant or breastfeeding. She is required to use birth control throughout the study.
All study medicines are given over 4-week cycles. Everyone taking part in this study will receive elranatamab as a shot under the skin. Participants will receive the first dose of carfilzomib to see if it is safe. Afterwards, they will receive weekly carfilzomib as an IV infusion (given directly into a vein). Participants will also receive weekly dexamethasone either by mouth (as a pill) or by IV infusion.
The investigators will examine the experiences of people receiving the study medicines. This will help participants determine if the study medicines are safe and can be used for multiple myeloma treatment. Participants will take part in this study for about 2 years after the first dose.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Elranatamab Drug: Carfilzomib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH CARFILZOMIB PLUS DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA|
|Actual Study Start Date :||December 14, 2022|
|Estimated Primary Completion Date :||November 15, 2024|
|Estimated Study Completion Date :||August 30, 2026|
Experimental: Dose Escalation
Elranatamab plus Carfilzomib and Dexamethasone
BCMA-CD3 bispecific antibody
Other Name: PF-06863135
Other Name: Kyprolis
- Number of participants with dose limiting toxicity (DLT) [ Time Frame: From Cycle 0 Day1 through the end of Cycle 1 or approximately 42 days. ]Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.
- Number of Participants With Treatment Emergent Adverse Events (TEAE) by Seriousness and Relationship to Treatment [ Time Frame: Assessed from baseline up to 90 days after last dose of study treatment. ]Counts of participants who had TEAEs, defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category.
- Number of Participants With Adverse Events (AE) characterized by type, frequency, severity. [ Time Frame: Assessed from baseline up to 90 days after last dose of study treatment. ]An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
- Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [ Time Frame: Accessed from baseline up to 90 days after the last dose of study treatment. ]Laboratory abnormalities as characterized by type, frequency, severity.
- Percent of participants with Best Overall Response (BOR) [ Time Frame: Assessed for approximately 2 years ]BOR is defined as the best response recorded from treatment start until disease progression/recurrence based on International Myeloma Working Group (IMWG) response criteria.
- Percentage of Participants with an Objective Response Rate (ORR) [ Time Frame: Assessed from enrollment for approximately 2 years. ]ORR rate is defined as the percent of participants having a Best Overall Response (BOR) of confirmed Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) according to IMWG.
- Percentage of participants with a complete response rate (CRR) [ Time Frame: Assessed for approximately 2 years ]Complete Response/ stringent Complete Response (CR+sCR) rate per IMWG response criteria as determined by investigator.
- Time to Response (TTR) [ Time Frame: Assessed for approximately 2 years. ]TTR is defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that is subsequently confirmed.
- Duration of Response (DOR) [ Time Frame: Assessed for approximately 2 years. ]DOR is defined, for participants with an objective response per IMWG criteria, as the time from the first documentation of objective response that is subsequently confirmed, until the first documentation of confirmed progressive disease (PD) per IMWG criteria.
- Duration of Complete Response (DOCR) [ Time Frame: Assessed for approximately 2 years. ]DOCR is defined, for participants with a Complete Response/stringent Complete Response (CR+sCR) per IMWG criteria, as the time from the first documentation of CR/sCR that is subsequently confirmed, until the first documentation of confirmed progressive disease (PD) per IMWG criteria.
- Time of Progression Free Survival (PFS) [ Time Frame: Assessed from enrollment until Progressive Disease or death for approximately 2 years. ]Progression free survival (IMWG response criteria)
- Time of Overall Survival (OS) [ Time Frame: Assessed for approximately 2 years ]OS is the duration of time from first dose of study treatment to death.
- Minimal Residual Disease (MRD) Negativity Rate [ Time Frame: Assessed for approximately 2 years ]MRD negativity rate is the proportion of participants acheiving CR+sCR with negative MRD, per IMWG sequencing criteria, from the date of first dose until the first documentation of confirmed progressive disease (PD), death or start of new anticancer therapy.
- Concentrations of carfilzomib [ Time Frame: Once approximately 7 weeks from enrollment. ]Pre-dose and post-dose concentrations of cafilzomib
- Concentrations of elranatamab [ Time Frame: Assessed with each dose during first cycle then approximately every 4 to 12 weeks while on treatment, approximately 2 years. ]Pre-dose and post-dose concentrations of elranatamab
- Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab [ Time Frame: Assessed approximately every 4 to 12 weeks while on treatment for approximately 2 years. ]Percent of participants with positive ADA to elranatamab when given in combination with carfilzomib and dexamethasone
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Prior diagnosis of multiple myeloma as defined by IMWG criteria.
Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL.
- Urinary M-protein excretion ≥200 mg/24 hours.
- Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
- Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy).
- ECOG performance status 0-1.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
- Not pregnant and willing to use contraception.
- Prior therapy with carfilzomib is allowed as long as the participant had (all apply): responded to most recent therapy with carfilzomib; Carfilzomib was not discontinued due to toxicity; Did not relapse within 60 days from discontinuation of carfilzomib; Will have at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment.
- Plasma cell leukemia, Smouldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome, Primary refractory MM
- Impaired cardiovascular function or clinically significant cardiovascular diseases.
- Participants with any active, uncontrolled bacterial, fungal, or viral infection.
- Stem cell transplant within 12 weeks prior to enrollment, or active graft versus host disease.
- 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 a BCMA-directed therapy.
- Live attenuated vaccine within 4 weeks of the first dose of study intervention.
- Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.
- Any of the following within 3 months of enrollment: erosive esophagitis, treatment resistant peptic ulcer, infectious or inflammatory bowel disease, pulmonary embolism or uncontrolled thromboembolic event.
- Participants who are unable to tolerate carfilzomib due to suspected carfilzomib-related congestive heart failure or thrombotic microangiopathy.
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): NCT05675449
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|United States, California|
|Beverly Hills Cancer Center||Recruiting|
|Beverly Hills, California, United States, 90211|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|
|Other Study ID Numbers:||
|First Posted:||January 9, 2023 Key Record Dates|
|Last Update Posted:||March 17, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
BCMA-CD3 bispecific antibody
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases