Back to resultsA Study to Learn About the Study Medicine (Elranatamab) Either Alone or in Combination With Dexamethasone in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment (MagnetisMM-9)
Primary Purpose
Multiple Myeloma
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Elranatamab
Elranatamab+ dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring BCMA, Multiple Myeloma, Relapse/Refractory, RRMM, Elranatamab, Dexamethasone, Targeted T-cell, MagnetisMM, MM9, Phase 2, B-Cell Maturation Antigen, monoclonal antibody
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
Measurable disease, as defined by at least 1 of the following:
- Serum M-protein >0.5 g/dL by SPEP
- Urinary M-protein excretion >200 mg/24 hours by UPEP
- Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
- Refractory to at least one IMiD
- Refractory to at least one PI
- Refractory to at least one anti-CD38 antibody
- Relapsed/refractory to last anti-myeloma regimen
- ECOG performance status ≤1
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
- Not pregnant and willing to use contraception
Exclusion Criteria:
- Smoldering multiple myeloma
- Active Plasma cell leukemia
- POEMS syndrome
- Amyloidosis
- Waldenström's macroglobulinemia
- Known active CNS involvement or clinical signs of myelomatous meningeal involvement
- Stem cell transplant within 12 weeks prior to enrollment or active GVHD
- Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
- 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 or Stage 0/1 malignancy with minimal risk of recurrence per investigator.
- Previous treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy.
- Live attenuated vaccine within 4 weeks of the first dose
- Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
Sites / Locations
- Mayo Clinic Hospital
- Mayo Clinic
- Poudre Valley Hospital
- Cancer Care & Hematology - Fort Collins
- UCHealth Cancer Care & Hematology - Greeley
- UCHealth Cancer Care & Hematology - Loveland
- UF Health Shands Cancer Hospital
- UF Health Shands Hospital
- Pikeville Medical Center, INC
- Tulane Cancer Center
- Tulane Medical Center
- Tufts Medical Center
- University of Michigan
- Henry Ford Hospital
- MSK Bergen
- Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
- Memorial Sloan Kettering Cancer Center
- MSK Nassau
- Cleveland Clinic Taussig Cancer Institute
- Fox Chase Cancer Center
- St. David's South Austin Medical Center
- Blood Cancer and Stem Cell Transplant Clinic
- Methodist Healthcare System of San Antonio dba Methodist Hospital
- Huntsman Cancer Institute, University of Utah
- Nagoya City University Hospital
- Kobe City Medical Center General Hospital
- National Cancer Center Hospital
- Japanese Red Cross Medical Center
- University Hospital,Kyoto Prefectural University of Medicine
- China Medical University Hospital
- National Cheng Kung University Hospital
- Taipei Veterans General Hospital
- National Taiwan University Hospital
- University Hospital Southampton NHS Foundation Trust
- The Royal Marsden NHS Foundation Trust
- University Hospitals Birmingham NHS Foundation Trust
- Guy's and St Thomas' NHS Foundation Trust
- King's College Hospital NHS Foundation Trust
- University College London Hospitals NHS Foundation Trust NIHR
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Part 1
Part 2A
Part 2B
Part 2C
Part 3
Arm Description
Evaluation of step-up priming dosing
Dose determination
Dose expansion
To explore higher dose intensity
To explore the combination with dexamethasone
Outcomes
Primary Outcome Measures
Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) (Part 1 and 2)
Cytokine release syndrome severity assessed by American Society for Transplantation and Cellular Therapy (ASTCT) criteria
Number of participants with overall response rate (ORR) per International Myeloma Working Group (IMWG) criteria (Part 3).
Treatment effect of elranatamab + dexamethasone on ORR per IMWG criteria.
Secondary Outcome Measures
Incidence of Dose Limiting Toxicities (Part 2A and 2C)
Frequency of Adverse Events
Adverse Events as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, timing, seriousness, and relationship to elranatamab
Frequency of laboratory abnormalities
Objective response rate
Objective response rate per International Myeloma Working Group (IMWG) response criteria
Complete Response Rate
Complete Response Rate per IMWG response criteria
Time to response
Time to response per IMWG response criteria
Duration of response
Duration of response per IMWG response criteria
Duration of complete response rate
Duration of complete response rate per IMWG response criteria
Progression Free Survival
Overall Survival
Minimal Residual Disease negativity rate
Minimal Residual Disease negativity rate assessed by central lab per IMWG sequencing criteria
Pre- and postdose concentrations of elranatamab
Pharmacokinetic of elranatamab
Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Immunogenicity of elranatamab
Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) (Part 3)
Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) when elranatamab is administered in combination with dexamethasone (Part 3)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05014412
Brief Title
A Study to Learn About the Study Medicine (Elranatamab) Either Alone or in Combination With Dexamethasone in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment
Acronym
MagnetisMM-9
Official Title
A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE A DOSING REGIMEN WITH TWO STEP-UP PRIMING DOSES AND LONGER DOSING INTERVALS OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
May 17, 2025 (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 purpose of Part 1 and Part 2 is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). The purpose of Part 3 of the study is to evaluate the safety and efficacy of elranatamab in combination with dexamethasone during the first 6 cycles followed by elranatamab monotherapy. This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses.
Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.
Detailed Description
The purpose of Part 1 and Part 2 of the study is to evaluate the safety (in particular the rate of Grade ≥ 2 CRS) of a step-up priming dose regimen of elranatamab in participants with relapsed/refractory multiple myeloma. The purpose of Part 3 is to evaluate the safety and efficacy of elranatamab in combination with dexamethasone during the first 6 cycles followed by elranatamab monotherapy. In addition, this study will assess the safety of different dosing regimens of elranatamab and if it can provide a clinical benefit in those participants. Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
BCMA, Multiple Myeloma, Relapse/Refractory, RRMM, Elranatamab, Dexamethasone, Targeted T-cell, MagnetisMM, MM9, Phase 2, B-Cell Maturation Antigen, monoclonal antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1
Arm Type
Experimental
Arm Description
Evaluation of step-up priming dosing
Arm Title
Part 2A
Arm Type
Experimental
Arm Description
Dose determination
Arm Title
Part 2B
Arm Type
Experimental
Arm Description
Dose expansion
Arm Title
Part 2C
Arm Type
Experimental
Arm Description
To explore higher dose intensity
Arm Title
Part 3
Arm Type
Experimental
Arm Description
To explore the combination with dexamethasone
Intervention Type
Drug
Intervention Name(s)
Elranatamab
Intervention Description
BCMA-CD3 bispecific antibody
Intervention Type
Drug
Intervention Name(s)
Elranatamab+ dexamethasone
Intervention Description
BCMA-CD3 bispecific antibody + corticosteroids (dexamethasone)
Primary Outcome Measure Information:
Title
Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) (Part 1 and 2)
Description
Cytokine release syndrome severity assessed by American Society for Transplantation and Cellular Therapy (ASTCT) criteria
Time Frame
Cycle 1 (28 days)
Title
Number of participants with overall response rate (ORR) per International Myeloma Working Group (IMWG) criteria (Part 3).
Description
Treatment effect of elranatamab + dexamethasone on ORR per IMWG criteria.
Time Frame
From the date of first dose until the first documentation of progressive disease (PD), death or start of new anticancer therapy, whichever occurs first (timeframe: approximately 2 years).
Secondary Outcome Measure Information:
Title
Incidence of Dose Limiting Toxicities (Part 2A and 2C)
Time Frame
28 days starting on the first dose of 116 or 152 mg
Title
Frequency of Adverse Events
Description
Adverse Events as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, timing, seriousness, and relationship to elranatamab
Time Frame
Up to 90 days after last dose and for approximately 2 years
Title
Frequency of laboratory abnormalities
Time Frame
Assessed at every cycles [each cycle approximately 28 days]
Title
Objective response rate
Description
Objective response rate per International Myeloma Working Group (IMWG) response criteria
Time Frame
Assessed approximately every 28 days and for approximately 2 years
Title
Complete Response Rate
Description
Complete Response Rate per IMWG response criteria
Time Frame
Assessed approximately every 28 days and for approximately 2 years
Title
Time to response
Description
Time to response per IMWG response criteria
Time Frame
Assessed approximately every 28 days and for approximately 2 years
Title
Duration of response
Description
Duration of response per IMWG response criteria
Time Frame
Assessed approximately every 28 days and for approximately 2 years
Title
Duration of complete response rate
Description
Duration of complete response rate per IMWG response criteria
Time Frame
Assessed approximately every 28 days and for approximately 2 years
Title
Progression Free Survival
Time Frame
Assessed approximately every 28 days for approximately 2 years
Title
Overall Survival
Time Frame
Approximately 2 years
Title
Minimal Residual Disease negativity rate
Description
Minimal Residual Disease negativity rate assessed by central lab per IMWG sequencing criteria
Time Frame
Assessed approximately every 12 months and for approximately 2 years
Title
Pre- and postdose concentrations of elranatamab
Description
Pharmacokinetic of elranatamab
Time Frame
Assessed approximately every 1 to 3 cycles [cycle of approximately 28 days]
Title
Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Description
Immunogenicity of elranatamab
Time Frame
Assessed approximately every 1 to 6 cycles [cycle of approximately 28 days]
Title
Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) (Part 3)
Description
Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) when elranatamab is administered in combination with dexamethasone (Part 3)
Time Frame
Cycle 1 (28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
Measurable disease, as defined by at least 1 of the following:
Serum M-protein >0.5 g/dL by SPEP
Urinary M-protein excretion >200 mg/24 hours by UPEP
Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
Refractory to at least one IMiD
Refractory to at least one PI
Refractory to at least one anti-CD38 antibody
Relapsed/refractory to last anti-myeloma regimen
ECOG performance status ≤1
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
Not pregnant and willing to use contraception
Exclusion Criteria:
Smoldering multiple myeloma
Active Plasma cell leukemia
POEMS syndrome
Amyloidosis
Waldenström's macroglobulinemia
Known active CNS involvement or clinical signs of myelomatous meningeal involvement
Stem cell transplant within 12 weeks prior to enrollment or active GVHD
Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
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 or Stage 0/1 malignancy with minimal risk of recurrence per investigator.
Previous treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy.
Live attenuated vaccine within 4 weeks of the first dose
Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
Known or suspected hypersensitivity to the study intervention, or any of its excipients or unable to tolerate systemic corticosteroids at doses planned to be administered in the study Part 3
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
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Cancer Care & Hematology - Fort Collins
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
UCHealth Cancer Care & Hematology - Greeley
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80634
Country
United States
Facility Name
UCHealth Cancer Care & Hematology - Loveland
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
UF Health Shands Cancer Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
UF Health Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Pikeville Medical Center, INC
City
Pikeville
State/Province
Kentucky
ZIP/Postal Code
41501
Country
United States
Facility Name
Tulane Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
MSK Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
MSK Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
St. David's South Austin Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Blood Cancer and Stem Cell Transplant Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Methodist Healthcare System of San Antonio dba Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Huntsman Cancer Institute, University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe-city
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
University Hospital,Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust NIHR
City
London
ZIP/Postal Code
W1T 7HA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C1071009
Description
To obtain contact information for a study center near you, click here.
URL
https://www.pfizerclinicaltrials.com/nct05014412
Description
www.MultipleMyelomaMM9Study.com
Learn more about this trial
A Study to Learn About the Study Medicine (Elranatamab) Either Alone or in Combination With Dexamethasone in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment
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