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| ID | Type | Description | Link |
|---|---|---|---|
| MAGNETISMM-20 | Other Identifier | Alias Study Number |
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The main purpose of the study is to evaluate the safety and tolerability of the combination of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept.
There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms. The first will evaluate the safety and tolerability of elranatamab when given in combination with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus maplirpacept.
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 in Part 1 will also receive weekly carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth (as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination with maplirpacept as an IV infusion (given directly into a vein)
The investigators will examine the experiences of people receiving the study medicines. This will help 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Dose Escalation | Experimental | Non randomized Elranatamab plus Carfilzomib and Dexamethasone |
|
| Part 2A Dose Escalation | Experimental | Non randomized Elranatamab plus Maplirpacept |
|
| Part 2B Dose Randomization | Experimental | Randomized dose level Elranatamab plus Maplirpacept |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elranatamab | Drug | BCMA-CD3 bispecific antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 Number of participants with dose limiting toxicity (DLT) | Dose limiting toxicity rate based on dose limiting toxicity evaluable participants. | From first dose of elranatamab through the end of the first cycle of combination treatment, about 42 days. |
| Part 2A Number of participants with dose limiting toxicity | Dose limiting toxicity based on dose limiting toxicity evaluable participants. | From the first dose of maplirpacept through the first cycle of combination treatment, about 64 days. |
| Part 2B Number of participants with dose limiting Toxicity | Dose limiting toxicity rate based on dose limiting toxicity evaluable participants. | From first dose of elranatamab through the first cycle of combination treatment, about 42 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants with Treatment Emergent Adverse Events (TEAE) by Seriousness and Relationship to 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. | Assessed from baseline up to 90 days after last dose of study treatment. |
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Inclusion Criteria:
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:
Part 1: 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).
Part 2: Received at least 3 prior lines of therapy for multiple myeloma who are refractory to at least one IMiD, one PI and one anti-CD38 antibody.
ECOG performance status 0-1.
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
Not pregnant or breastfeeding and willing to use contraception.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| Beverly Hills Cancer Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| Carfilzomib | Drug | proteasome inhibitor |
|
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| Maplirpacept | Drug | CD47-SIRP alpha-directed |
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| Part 1: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity. | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Assessed from baseline up to 90 days after last dose of study treatment. |
| Part 1: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities | Laboratory abnormalities as characterized by type, frequency, severity. | Accessed from baseline up to 90 days after the last dose of study treatment. |
| Part 1: Percent of participants with Best Overall Response (BOR) | BOR is defined as the best response recorded from treatment start until disease progression/recurrence based on International Myeloma Working Group (IMWG) response criteria. | Assessed for approximately 2 years |
| Part 1: Percentage of Participants with an Objective Response Rate (ORR) | 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. | Assessed from enrollment for approximately 2 years. |
| Part 1: Percentage of participants with a complete response rate (CRR) | Complete Response/ stringent Complete Response (CR+sCR) rate per IMWG response criteria as determined by investigator. | Assessed for approximately 2 years |
| Part 1: Time to Response (TTR) | 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. | Assessed for approximately 2 years. |
| Part 1: Duration of Response (DOR) | 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. | Assessed for approximately 2 years. |
| Part 1: Duration of Complete Response (DOCR) | 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. | Assessed for approximately 2 years. |
| Part 1: Time of Progression Free Survival (PFS) | Progression free survival (IMWG response criteria) | Assessed from enrollment until Progressive Disease or death for approximately 2 years. |
| Part 1: Time of Overall Survival (OS) | OS is the duration of time from first dose of study treatment to death. | Assessed for approximately 2 years |
| Part 1: Minimal Residual Disease (MRD) Negativity Rate | 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. | Assessed for approximately 2 years |
| Part 1: Concentrations of carfilzomib | Pre-dose and post-dose concentrations of cafilzomib | Once approximately 7 weeks from enrollment. |
| Part 1: Concentrations of elranatamab | Pre-dose and post-dose concentrations of elranatamab | Assessed for approximately 2 years. |
| Part 1: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab | Percent of participants with positive ADA to elranatamab when given in combination with carfilzomib and dexamethasone | Assessed for approximately 2 years. |
| Part 2A: Number of Participants with Treatment Emergent Adverse Events (TEAE) by Seriousness and Relationship to 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. | Assessed from baseline up to 90 days after last dose of study treatment. |
| Part 2A: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity. | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Assessed from baseline up to 90 days after last dose of study treatment. |
| Part 2A: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities | Laboratory abnormalities as characterized by type, frequency, severity. | Accessed from baseline up to 90 days after the last dose of study treatment. |
| Part 2A: Percent of participants with Best Overall Response (BOR) | BOR is defined as the best response recorded from treatment start until disease progression/recurrence based on International Myeloma Working Group (IMWG) response criteria. | Assessed for approximately 2 years |
| Part 2A: Percentage of Participants with an Objective Response Rate (ORR) | 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. | Assessed from enrollment for approximately 2 years. |
| Part 2A: Percentage of participants with a complete response rate (CRR) | Complete Response/ stringent Complete Response (CR+sCR) rate per IMWG response criteria as determined by investigator. | Assessed for approximately 2 years |
| Part 2A: Time to Response (TTR) | 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. | Assessed for approximately 2 years. |
| Part 2A: Duration of Response (DOR) | 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. | Assessed for approximately 2 years. |
| Part 2A: Duration of Complete Response (DOCR) | 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. | Assessed for approximately 2 years. |
| Part 2A: Time of Progression Free Survival (PFS) | Progression free survival (IMWG response criteria) | Assessed from enrollment until Progressive Disease or death for approximately 2 years. |
| Part 2A: Time of Overall Survival (OS) | OS is the duration of time from first dose of study treatment to death. | Assessed for approximately 2 years |
| Part 2A: Minimal Residual Disease (MRD) Negativity Rate | MRD negativity rate is the proportion of participants achieving 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. | Assessed for approximately 2 years |
| Part 2A: Concentrations of maplirpacept | Pre-dose and post-dose concentrations of maplirpacept | Assessed for approximately 2 years. |
| Part 2A: Concentrations of elranatamab | Pre-dose and post-dose concentrations of elranatamab | Assessed for approximately 2 years. |
| Part 2A: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab | Percent of participants with positive ADA to elranatamab when given in combination with maplirpacept | Assessed for approximately 2 years. |
| Part 2A: Percentage of participants with positive anti-drug antibodies (ADA) against maplirpacept | Percent of participants with positive ADA to elranatamab when given in combination with elranatamab | Assessed for approximately 2 years. |
| Part 2B: Number of Participants with Treatment Emergent Adverse Events (TEAE) by Seriousness and Relationship to 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. | Assessed from baseline up to 90 days after last dose of study treatment. |
| Part 2B: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity. | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Assessed from baseline up to 90 days after last dose of study treatment. |
| Part 2B: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities | Laboratory abnormalities as characterized by type, frequency, severity. | Accessed from baseline up to 90 days after the last dose of study treatment. |
| Part 2B: Percent of participants with Best Overall Response (BOR) | BOR is defined as the best response recorded from treatment start until disease progression/recurrence based on International Myeloma Working Group (IMWG) response criteria. | Assessed for approximately 2 years |
| Part 2B: Percentage of Participants with an Objective Response Rate (ORR) | 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. | Assessed from enrollment for approximately 2 years. |
| Part 2B: Percentage of participants with a complete response rate (CRR) | Complete Response/ stringent Complete Response (CR+sCR) rate per IMWG response criteria as determined by investigator. | Assessed for approximately 2 years |
| Part 2B: Time to Response (TTR) | 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. | Assessed for approximately 2 years. |
| Part 2B: Duration of Response (DOR) | 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. | Assessed for approximately 2 years. |
| Part 2B: Duration of Complete Response (DOCR) | 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. | Assessed for approximately 2 years. |
| Part 2B: Time of Progression Free Survival (PFS) | Progression free survival (IMWG response criteria) | Assessed from enrollment until Progressive Disease or death for approximately 2 years. |
| Part 2B: Time of Overall Survival (OS) | OS is the duration of time from first dose of study treatment to death. | Assessed for approximately 2 years |
| Part 2B: Minimal Residual Disease (MRD) Negativity Rate | MRD negativity rate is the proportion of participants achieving 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. | Assessed for approximately 2 years |
| Part 2B: Concentrations of maplirpacept | Pre-dose and post-dose concentrations of maplirpacept | Assessed for approximately 2 years. |
| Part 2B: Concentrations of elranatamab | Pre-dose and post-dose concentrations of elranatamab | Assessed for approximately 2 years. |
| Part 2B: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab | Percent of participants with positive ADA to elranatamab when given in combination with maplirpacept | Assessed for approximately 2 years. |
| Part 2B: Percentage of participants with positive anti-drug antibodies (ADA) against maplirpacept | Percent of participants with positive ADA to elranatamab when given in combination with elranatamab | Assessed for approximately 2 years. |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Clinical Research Advisors (Encino Satellite Location) | Encino | California | 91316 | United States |
| Clinical Research Advisors (Korea Town Satellite Location) | Los Angeles | California | 90020 | United States |
| Clinical Research Advisors (West Hollywood Satellite Location) | Los Angeles | California | 90048 | United States |
| Sylvester Comprehensive Cancer Center - Aventura | Aventura | Florida | 33180 | United States |
| Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center | Coral Gables | Florida | 33146 | United States |
| Sylvester Comprehensive Cancer Center - Coral Springs | Coral Springs | Florida | 33065 | United States |
| University of Miami Hospital and Clinics - Deerfield Beach | Deerfield Beach | Florida | 33442 | United States |
| Sylvester Comprehensive Cancer Center - Hollywood | Hollywood | Florida | 33021 | United States |
| Griffin Cancer Research Building (GCRB) | Miami | Florida | 33136 | United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| University of Miami Hospital and Clinics | Miami | Florida | 33136 | United States |
| Sylvester Comprehensive Cancer Center - Kendall | Miami | Florida | 33176 | United States |
| Sylvester Comprehensive Cancer Center - Plantation | Plantation | Florida | 33324 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Emory University Administration Office | Atlanta | Georgia | 30322 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| State University of Iowa, Division of Sponsored Programs | Iowa City | Iowa | 52242 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Oncology Investigational Drug Service,Department of Pharmacy Services | Baltimore | Maryland | 21231 | United States |
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| Johns Hopkins University Cancer Immunology/GI Oncology | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana Farber/Mass General Brigham Cancer Care, Inc | Boston | Massachusetts | 02115 | United States |
| MSK Monmouth | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). | New York | New York | 10021 | United States |
| Memorial Sloan Kettering Cancer Center - Main Campus | New York | New York | 10065 | United States |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Division of Hematology Hadassah Medical Center - Ein Kerem | Jerusalem | 9112001 | Israel |
| The Research Fund of Hadassah Medical Organization (R.A.) | Jerusalem | 9112001 | Israel |
| Hematology Division Davidoff Center, Rabin Medical Center, Beilinson Hospital | Petah Tikva | 4941492 | Israel |
| Rabin Medical Center | Petah Tikva | 4941492 | Israel |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C524865 | carfilzomib |
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