search
Back to results

A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma (MagnetisMM-20)

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Elranatamab
Carfilzomib
Maplirpacept
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring elranatamab, relapsed, RRMM, BCMA, C1071020, MagnetisMM, maplipacelt, PF-06863135, carfilzomib, Bispecific antibody, PF-07901801, TTI-622, SIRPα, CD47

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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). 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. 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. Exclusion Criteria: 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. Part 1: Previous treatment with a BCMA-directed therapy. Part 2: Previous treatment with any anti-BCMA directed therapy, with the exception of CAR-T. Previous treatment with a CD47-SIRP alpha-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.

Sites / Locations

  • Beverly Hills Cancer CenterRecruiting
  • Sylvester Comprehensive Cancer Center - Aventura
  • Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
  • Sylvester Comprehensive Cancer Center - Coral Springs
  • University of Miami Hospital and Clinics - Deerfield Beach
  • Sylvester Comprehensive Cancer Center - Hollywood
  • Sylvester Comprehensive Cancer Center
  • Sylvester Comprehensive Cancer Center - Kendall
  • Sylvester Comprehensive Cancer Center - Plantation
  • University of Iowa Hospitals and ClinicsRecruiting
  • Oncology Investigational Drug Service,Department of Pharmacy Services
  • Johns Hopkins Medicine
  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part 1 Dose Escalation

Part 2A Dose Escalation

Part 2B Dose Randomization

Arm Description

Non randomized Elranatamab plus Carfilzomib and Dexamethasone

Non randomized Elranatamab plus Maplirpacept

Randomized dose level Elranatamab plus Maplirpacept

Outcomes

Primary Outcome Measures

Part 1 Number of participants with dose limiting toxicity (DLT)
Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.
Part 2A Number of participants with dose limiting toxicity
Dose limiting toxicity based on dose limiting toxicity evaluable participants.
Part 2B Number of participants with dose limiting Toxicity
Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.

Secondary Outcome Measures

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.
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.
Part 1: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities
Laboratory abnormalities as characterized by type, frequency, severity.
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.
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.
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.
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.
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.
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.
Part 1: Time of Progression Free Survival (PFS)
Progression free survival (IMWG response criteria)
Part 1: Time of Overall Survival (OS)
OS is the duration of time from first dose of study treatment to death.
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.
Part 1: Concentrations of carfilzomib
Pre-dose and post-dose concentrations of cafilzomib
Part 1: Concentrations of elranatamab
Pre-dose and post-dose concentrations of elranatamab
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
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.
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.
Part 2A: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities
Laboratory abnormalities as characterized by type, frequency, severity.
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.
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.
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.
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.
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.
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.
Part 2A: Time of Progression Free Survival (PFS)
Progression free survival (IMWG response criteria)
Part 2A: Time of Overall Survival (OS)
OS is the duration of time from first dose of study treatment to death.
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.
Part 2A: Concentrations of maplirpacept
Pre-dose and post-dose concentrations of maplirpacept
Part 2A: Concentrations of elranatamab
Pre-dose and post-dose concentrations of elranatamab
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
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
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.
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.
Part 2B: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities
Laboratory abnormalities as characterized by type, frequency, severity.
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.
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.
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.
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.
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.
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.
Part 2B: Time of Progression Free Survival (PFS)
Progression free survival (IMWG response criteria)
Part 2B: Time of Overall Survival (OS)
OS is the duration of time from first dose of study treatment to death.
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.
Part 2B: Concentrations of maplirpacept
Pre-dose and post-dose concentrations of maplirpacept
Part 2B: Concentrations of elranatamab
Pre-dose and post-dose concentrations of elranatamab
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
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

Full Information

First Posted
December 7, 2022
Last Updated
October 4, 2023
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT05675449
Brief Title
A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma
Acronym
MagnetisMM-20
Official Title
A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH CARFILZOMIB PLUS DEXAMETHASONE AND ELRANATAMAB IN COMBINATION WITH PF-07901801 IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
August 19, 2025 (Anticipated)
Study Completion Date
September 19, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
elranatamab, relapsed, RRMM, BCMA, C1071020, MagnetisMM, maplipacelt, PF-06863135, carfilzomib, Bispecific antibody, PF-07901801, TTI-622, SIRPα, CD47

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1 Dose Escalation
Arm Type
Experimental
Arm Description
Non randomized Elranatamab plus Carfilzomib and Dexamethasone
Arm Title
Part 2A Dose Escalation
Arm Type
Experimental
Arm Description
Non randomized Elranatamab plus Maplirpacept
Arm Title
Part 2B Dose Randomization
Arm Type
Experimental
Arm Description
Randomized dose level Elranatamab plus Maplirpacept
Intervention Type
Drug
Intervention Name(s)
Elranatamab
Other Intervention Name(s)
PF-06863135
Intervention Description
BCMA-CD3 bispecific antibody
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Other Intervention Name(s)
Kyprolis
Intervention Description
proteasome inhibitor
Intervention Type
Drug
Intervention Name(s)
Maplirpacept
Other Intervention Name(s)
PF-07901801, TTI-622
Intervention Description
CD47-SIRP alpha-directed
Primary Outcome Measure Information:
Title
Part 1 Number of participants with dose limiting toxicity (DLT)
Description
Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.
Time Frame
From first dose of elranatamab through the end of the first cycle of combination treatment, about 42 days.
Title
Part 2A Number of participants with dose limiting toxicity
Description
Dose limiting toxicity based on dose limiting toxicity evaluable participants.
Time Frame
From the first dose of maplirpacept through the first cycle of combination treatment, about 64 days.
Title
Part 2B Number of participants with dose limiting Toxicity
Description
Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.
Time Frame
From first dose of elranatamab through the first cycle of combination treatment, about 42 days.
Secondary Outcome Measure Information:
Title
Part 1: Number of Participants with Treatment Emergent Adverse Events (TEAE) by Seriousness and Relationship to Treatment
Description
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.
Time Frame
Assessed from baseline up to 90 days after last dose of study treatment.
Title
Part 1: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity.
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame
Assessed from baseline up to 90 days after last dose of study treatment.
Title
Part 1: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities
Description
Laboratory abnormalities as characterized by type, frequency, severity.
Time Frame
Accessed from baseline up to 90 days after the last dose of study treatment.
Title
Part 1: Percent of participants with Best Overall Response (BOR)
Description
BOR is defined as the best response recorded from treatment start until disease progression/recurrence based on International Myeloma Working Group (IMWG) response criteria.
Time Frame
Assessed for approximately 2 years
Title
Part 1: Percentage of Participants with an Objective Response Rate (ORR)
Description
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.
Time Frame
Assessed from enrollment for approximately 2 years.
Title
Part 1: Percentage of participants with a complete response rate (CRR)
Description
Complete Response/ stringent Complete Response (CR+sCR) rate per IMWG response criteria as determined by investigator.
Time Frame
Assessed for approximately 2 years
Title
Part 1: Time to Response (TTR)
Description
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.
Time Frame
Assessed for approximately 2 years.
Title
Part 1: Duration of Response (DOR)
Description
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.
Time Frame
Assessed for approximately 2 years.
Title
Part 1: Duration of Complete Response (DOCR)
Description
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 Frame
Assessed for approximately 2 years.
Title
Part 1: Time of Progression Free Survival (PFS)
Description
Progression free survival (IMWG response criteria)
Time Frame
Assessed from enrollment until Progressive Disease or death for approximately 2 years.
Title
Part 1: Time of Overall Survival (OS)
Description
OS is the duration of time from first dose of study treatment to death.
Time Frame
Assessed for approximately 2 years
Title
Part 1: Minimal Residual Disease (MRD) Negativity Rate
Description
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.
Time Frame
Assessed for approximately 2 years
Title
Part 1: Concentrations of carfilzomib
Description
Pre-dose and post-dose concentrations of cafilzomib
Time Frame
Once approximately 7 weeks from enrollment.
Title
Part 1: Concentrations of elranatamab
Description
Pre-dose and post-dose concentrations of elranatamab
Time Frame
Assessed for approximately 2 years.
Title
Part 1: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab
Description
Percent of participants with positive ADA to elranatamab when given in combination with carfilzomib and dexamethasone
Time Frame
Assessed for approximately 2 years.
Title
Part 2A: Number of Participants with Treatment Emergent Adverse Events (TEAE) by Seriousness and Relationship to Treatment
Description
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.
Time Frame
Assessed from baseline up to 90 days after last dose of study treatment.
Title
Part 2A: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity.
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame
Assessed from baseline up to 90 days after last dose of study treatment.
Title
Part 2A: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities
Description
Laboratory abnormalities as characterized by type, frequency, severity.
Time Frame
Accessed from baseline up to 90 days after the last dose of study treatment.
Title
Part 2A: Percent of participants with Best Overall Response (BOR)
Description
BOR is defined as the best response recorded from treatment start until disease progression/recurrence based on International Myeloma Working Group (IMWG) response criteria.
Time Frame
Assessed for approximately 2 years
Title
Part 2A: Percentage of Participants with an Objective Response Rate (ORR)
Description
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.
Time Frame
Assessed from enrollment for approximately 2 years.
Title
Part 2A: Percentage of participants with a complete response rate (CRR)
Description
Complete Response/ stringent Complete Response (CR+sCR) rate per IMWG response criteria as determined by investigator.
Time Frame
Assessed for approximately 2 years
Title
Part 2A: Time to Response (TTR)
Description
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.
Time Frame
Assessed for approximately 2 years.
Title
Part 2A: Duration of Response (DOR)
Description
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.
Time Frame
Assessed for approximately 2 years.
Title
Part 2A: Duration of Complete Response (DOCR)
Description
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 Frame
Assessed for approximately 2 years.
Title
Part 2A: Time of Progression Free Survival (PFS)
Description
Progression free survival (IMWG response criteria)
Time Frame
Assessed from enrollment until Progressive Disease or death for approximately 2 years.
Title
Part 2A: Time of Overall Survival (OS)
Description
OS is the duration of time from first dose of study treatment to death.
Time Frame
Assessed for approximately 2 years
Title
Part 2A: Minimal Residual Disease (MRD) Negativity Rate
Description
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.
Time Frame
Assessed for approximately 2 years
Title
Part 2A: Concentrations of maplirpacept
Description
Pre-dose and post-dose concentrations of maplirpacept
Time Frame
Assessed for approximately 2 years.
Title
Part 2A: Concentrations of elranatamab
Description
Pre-dose and post-dose concentrations of elranatamab
Time Frame
Assessed for approximately 2 years.
Title
Part 2A: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab
Description
Percent of participants with positive ADA to elranatamab when given in combination with maplirpacept
Time Frame
Assessed for approximately 2 years.
Title
Part 2A: Percentage of participants with positive anti-drug antibodies (ADA) against maplirpacept
Description
Percent of participants with positive ADA to elranatamab when given in combination with elranatamab
Time Frame
Assessed for approximately 2 years.
Title
Part 2B: Number of Participants with Treatment Emergent Adverse Events (TEAE) by Seriousness and Relationship to Treatment
Description
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.
Time Frame
Assessed from baseline up to 90 days after last dose of study treatment.
Title
Part 2B: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity.
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame
Assessed from baseline up to 90 days after last dose of study treatment.
Title
Part 2B: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities
Description
Laboratory abnormalities as characterized by type, frequency, severity.
Time Frame
Accessed from baseline up to 90 days after the last dose of study treatment.
Title
Part 2B: Percent of participants with Best Overall Response (BOR)
Description
BOR is defined as the best response recorded from treatment start until disease progression/recurrence based on International Myeloma Working Group (IMWG) response criteria.
Time Frame
Assessed for approximately 2 years
Title
Part 2B: Percentage of Participants with an Objective Response Rate (ORR)
Description
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.
Time Frame
Assessed from enrollment for approximately 2 years.
Title
Part 2B: Percentage of participants with a complete response rate (CRR)
Description
Complete Response/ stringent Complete Response (CR+sCR) rate per IMWG response criteria as determined by investigator.
Time Frame
Assessed for approximately 2 years
Title
Part 2B: Time to Response (TTR)
Description
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.
Time Frame
Assessed for approximately 2 years.
Title
Part 2B: Duration of Response (DOR)
Description
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.
Time Frame
Assessed for approximately 2 years.
Title
Part 2B: Duration of Complete Response (DOCR)
Description
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 Frame
Assessed for approximately 2 years.
Title
Part 2B: Time of Progression Free Survival (PFS)
Description
Progression free survival (IMWG response criteria)
Time Frame
Assessed from enrollment until Progressive Disease or death for approximately 2 years.
Title
Part 2B: Time of Overall Survival (OS)
Description
OS is the duration of time from first dose of study treatment to death.
Time Frame
Assessed for approximately 2 years
Title
Part 2B: Minimal Residual Disease (MRD) Negativity Rate
Description
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.
Time Frame
Assessed for approximately 2 years
Title
Part 2B: Concentrations of maplirpacept
Description
Pre-dose and post-dose concentrations of maplirpacept
Time Frame
Assessed for approximately 2 years.
Title
Part 2B: Concentrations of elranatamab
Description
Pre-dose and post-dose concentrations of elranatamab
Time Frame
Assessed for approximately 2 years.
Title
Part 2B: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab
Description
Percent of participants with positive ADA to elranatamab when given in combination with maplirpacept
Time Frame
Assessed for approximately 2 years.
Title
Part 2B: Percentage of participants with positive anti-drug antibodies (ADA) against maplirpacept
Description
Percent of participants with positive ADA to elranatamab when given in combination with elranatamab
Time Frame
Assessed for approximately 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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). 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. 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. Exclusion Criteria: 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. Part 1: Previous treatment with a BCMA-directed therapy. Part 2: Previous treatment with any anti-BCMA directed therapy, with the exception of CAR-T. Previous treatment with a CD47-SIRP alpha-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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
Sylvester Comprehensive Cancer Center - Aventura
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sylvester Comprehensive Cancer Center - Coral Springs
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Miami Hospital and Clinics - Deerfield Beach
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sylvester Comprehensive Cancer Center - Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sylvester Comprehensive Cancer Center - Kendall
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sylvester Comprehensive Cancer Center - Plantation
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Investigational Drug Service,Department of Pharmacy Services
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C1071020
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma

We'll reach out to this number within 24 hrs