Multiple MyelomaPhase 1MagnetisMM-20NCT05675449
A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma
A Phase 1 study testing Elranatamab, Carfilzomib and Maplirpacept in people with Multiple Myeloma, run by Pfizer at 36 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Elranatamab, Carfilzomib and Maplirpacept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 14 Dec 2022to 29 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
- Part 1: Prior treatment with carfilzomib
- 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.
- Intolerance to or participants who have had a severe (Grade ≥3) allergic or anaphylactic reaction to antibodies or therapeutic proteins
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States31 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Administration Office
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
Winship Cancer Institute
Atlanta, Georgia, 30322
Sylvester Comprehensive Cancer Center - Aventura
Aventura, Florida, 33180
Oncology Investigational Drug Service,Department of Pharmacy Services
Baltimore, Maryland, 21231
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Johns Hopkins University Cancer Immunology/GI Oncology
Baltimore, Maryland, 21287
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber/Mass General Brigham Cancer Care, Inc
Boston, Massachusetts, 02115
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables, Florida, 33146
Sylvester Comprehensive Cancer Center - Coral Springs
Coral Springs, Florida, 33065
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, 33442
Clinical Research Advisors (Encino Satellite Location)
Encino, California, 91316
Sylvester Comprehensive Cancer Center - Hollywood
Hollywood, Florida, 33021
State University of Iowa, Division of Sponsored Programs
Iowa City, Iowa, 52242
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Clinical Research Advisors (Korea Town Satellite Location)
Los Angeles, California, 90020
Clinical Research Advisors (West Hollywood Satellite Location)
Los Angeles, California, 90048
Griffin Cancer Research Building (GCRB)
Miami, Florida, 33136
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
University of Miami Hospital and Clinics
Miami, Florida, 33136
Sylvester Comprehensive Cancer Center - Kendall
Miami, Florida, 33176
MSK Monmouth
Middletown, New Jersey, 07748
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
Sylvester Comprehensive Cancer Center - Plantation
Plantation, Florida, 33324
Israel5 sites
Rambam Health Care Campus
Haifa, 3109601
Division of Hematology Hadassah Medical Center - Ein Kerem
Jerusalem, 9112001
The Research Fund of Hadassah Medical Organization (R.A.)
Jerusalem, 9112001
Hematology Division Davidoff Center, Rabin Medical Center, Beilinson Hospital
Petah Tikva, 4941492
Rabin Medical Center
Petah Tikva, 4941492
About this study
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
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.
Read more
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.
- Conditions
- Multiple Myeloma
- Being tested
- Elranatamab, Carfilzomib, Maplirpacept
- Keywords
- elranatamab, relapsed, RRMM, BCMA, C1071020, MagnetisMM, maplipacelt, PF-06863135, carfilzomib, Bispecific antibody, PF-07901801, TTI-622, SIRPα, CD47
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElranatamabDrug
Also called PF-06863135
BCMA-CD3 bispecific antibody
CarfilzomibDrug
Also called Kyprolis
proteasome inhibitor
MaplirpaceptDrug
Also called PF-07901801, TTI-622
CD47-SIRP alpha-directed
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation | Experimental | Non randomized Elranatamab plus Carfilzomib and Dexamethasone Receives: Drug: Elranatamab; Drug: Carfilzomib |
| Part 2A Dose Escalation | Experimental | Non randomized Elranatamab plus Maplirpacept Receives: Drug: Elranatamab; Drug: Maplirpacept |
| Part 2B Dose Randomization | Experimental | Randomized dose level Elranatamab plus Maplirpacept Receives: Drug: Elranatamab; Drug: Maplirpacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 Number of participants with dose limiting toxicity (DLT)
Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.
Measured: 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.
Measured: 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.
Measured: From first dose of elranatamab through the first cycle of combination treatment, about 42 days.
Secondary outcomes (47)
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.
Measured: Assessed from baseline up to 90 days after last dose of study treatment.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed for approximately 2 years.
Part 1: Time of Progression Free Survival (PFS)
Progression free survival (IMWG response criteria)
Measured: 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.
Measured: 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.
Measured: Assessed for approximately 2 years
Part 1: Concentrations of carfilzomib
Pre-dose and post-dose concentrations of cafilzomib
Measured: Once approximately 7 weeks from enrollment.
Part 1: Concentrations of elranatamab
Pre-dose and post-dose concentrations of elranatamab
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed for approximately 2 years.
Part 2A: Time of Progression Free Survival (PFS)
Progression free survival (IMWG response criteria)
Measured: 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.
Measured: 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.
Measured: Assessed for approximately 2 years
Part 2A: Concentrations of maplirpacept
Pre-dose and post-dose concentrations of maplirpacept
Measured: Assessed for approximately 2 years.
Part 2A: Concentrations of elranatamab
Pre-dose and post-dose concentrations of elranatamab
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed for approximately 2 years.
Part 2B: Time of Progression Free Survival (PFS)
Progression free survival (IMWG response criteria)
Measured: 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.
Measured: 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.
Measured: Assessed for approximately 2 years
Part 2B: Concentrations of maplirpacept
Pre-dose and post-dose concentrations of maplirpacept
Measured: Assessed for approximately 2 years.
Part 2B: Concentrations of elranatamab
Pre-dose and post-dose concentrations of elranatamab
Measured: 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
Measured: 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
Measured: Assessed for approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start14 Dec 2022
- Primary completion11 Mar 2026
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675449
- Sponsor's protocol ID
- C1071020
- Other IDs
- MAGNETISMM-20
- Acronym
- MagnetisMM-20
- Status last verified
- Aug 2026
- First submitted
- 7 Dec 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05675449
- Acronym / sponsor ID
- MagnetisMM-20 / C1071020
- Conditions
- Multiple Myeloma
- Keywords
- elranatamab, relapsed, RRMM, BCMA, C1071020, MagnetisMM, maplipacelt, PF-06863135
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation | Experimental | Drug: Elranatamab, Drug: CarfilzomibNon randomized Elranatamab plus Carfilzomib and Dexamethasone |
| Part 2A Dose Escalation | Experimental | Drug: Elranatamab, Drug: MaplirpaceptNon randomized Elranatamab plus Maplirpacept |
| Part 2B Dose Randomization | Experimental | Drug: Elranatamab, Drug: MaplirpaceptRandomized dose level Elranatamab plus Maplirpacept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElranatamabAlso: PF-06863135BCMA-CD3 bispecific antibody | Drug | Part 1 Dose Escalation, Part 2A Dose Escalation, Part 2B Dose Randomization |
| CarfilzomibAlso: Kyprolisproteasome inhibitor | Drug | Part 1 Dose Escalation |
| MaplirpaceptAlso: PF-07901801, TTI-622CD47-SIRP alpha-directed | Drug | Part 2A Dose Escalation, Part 2B Dose Randomization |
Primary outcome
Part 1 Number of participants with dose limiting toxicity (DLT)
Time frame: From first dose of elranatamab through the end of the first cycle of combination treatment, about 42 days.
Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.
Part 2A Number of participants with dose limiting toxicity
Time frame: From the first dose of maplirpacept through the first cycle of combination treatment, about 64 days.
Dose limiting toxicity based on dose limiting toxicity evaluable participants.
Part 2B Number of participants with dose limiting Toxicity
Time frame: From first dose of elranatamab through the first cycle of combination treatment, about 42 days.
Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.
47 secondary outcomes
Part 1: 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.
Part 1: 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.
Part 1: 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.
Part 1: Percent of participants with Best Overall Response (BOR)
Time frame: Assessed for approximately 2 years
Part 1: Percentage of Participants with an Objective Response Rate (ORR)
Time frame: Assessed from enrollment for approximately 2 years.
Part 1: Percentage of participants with a complete response rate (CRR)
Time frame: Assessed for approximately 2 years
Part 1: Time to Response (TTR)
Time frame: Assessed for approximately 2 years.
Part 1: Duration of Response (DOR)
Time frame: Assessed for approximately 2 years.
Part 1: Duration of Complete Response (DOCR)
Time frame: Assessed for approximately 2 years.
Part 1: Time of Progression Free Survival (PFS)
Time frame: Assessed from enrollment until Progressive Disease or death for approximately 2 years.
Part 1: Time of Overall Survival (OS)
Time frame: Assessed for approximately 2 years
Part 1: Minimal Residual Disease (MRD) Negativity Rate
Time frame: Assessed for approximately 2 years
Part 1: Concentrations of carfilzomib
Time frame: Once approximately 7 weeks from enrollment.
Part 1: Concentrations of elranatamab
Time frame: Assessed for approximately 2 years.
Part 1: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab
Time frame: Assessed for approximately 2 years.
Part 2A: 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.
Part 2A: 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.
Part 2A: 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.
Part 2A: Percent of participants with Best Overall Response (BOR)
Time frame: Assessed for approximately 2 years
Part 2A: Percentage of Participants with an Objective Response Rate (ORR)
Time frame: Assessed from enrollment for approximately 2 years.
Part 2A: Percentage of participants with a complete response rate (CRR)
Time frame: Assessed for approximately 2 years
Part 2A: Time to Response (TTR)
Time frame: Assessed for approximately 2 years.
Part 2A: Duration of Response (DOR)
Time frame: Assessed for approximately 2 years.
Part 2A: Duration of Complete Response (DOCR)
Time frame: Assessed for approximately 2 years.
Part 2A: Time of Progression Free Survival (PFS)
Time frame: Assessed from enrollment until Progressive Disease or death for approximately 2 years.
Part 2A: Time of Overall Survival (OS)
Time frame: Assessed for approximately 2 years
Part 2A: Minimal Residual Disease (MRD) Negativity Rate
Time frame: Assessed for approximately 2 years
Part 2A: Concentrations of maplirpacept
Time frame: Assessed for approximately 2 years.
Part 2A: Concentrations of elranatamab
Time frame: Assessed for approximately 2 years.
Part 2A: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab
Time frame: Assessed for approximately 2 years.
Part 2A: Percentage of participants with positive anti-drug antibodies (ADA) against maplirpacept
Time frame: Assessed for approximately 2 years.
Part 2B: 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.
Part 2B: 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.
Part 2B: 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.
Part 2B: Percent of participants with Best Overall Response (BOR)
Time frame: Assessed for approximately 2 years
Part 2B: Percentage of Participants with an Objective Response Rate (ORR)
Time frame: Assessed from enrollment for approximately 2 years.
Part 2B: Percentage of participants with a complete response rate (CRR)
Time frame: Assessed for approximately 2 years
Part 2B: Time to Response (TTR)
Time frame: Assessed for approximately 2 years.
Part 2B: Duration of Response (DOR)
Time frame: Assessed for approximately 2 years.
Part 2B: Duration of Complete Response (DOCR)
Time frame: Assessed for approximately 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elranatamab, Carfilzomib and Maplirpacept in people with Multiple Myeloma, run by Pfizer at 36 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 Number of participants with dose limiting toxicity (DLT) (time frame: From first dose of elranatamab through the end of the first cycle of combination treatment, about 42 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.