Back to resultsMAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma
Primary Purpose
Relapsed or Refractory Multiple Myeloma
Status
Active
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Elranatamab (PF-06863135)
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of multiple myeloma (IMWG criteria)
Measurable disease, as defined by at least 1 of the following
- Serum myeloma (M) protein ≥0.5 g/dL (5 g/L)
- Urine M protein ≥200 mg/24 h
- Serum free light chain (FLC) >100 mg/L (10 mg/dL) with abnormal kappa:lambda ratio
- Participants must have progressed on or been intolerant of at least 3 prior therapies including proteasome inhibitor, IMID drug and anti-CD38 antibody, either in combination or as a single agent
- ECOG PS 0, 1 or 2. PS 3 is permitted if PS is due solely to bone pain
- Adequate bone marrow, hematological, kidney and liver function
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1
- Not pregnant and willing to use contraception
Exclusion Criteria:
- POEMS syndrome
- 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
- History of active autoimmune disorders
- Any form of primary immunodeficiency
- History of severe immune-mediated adverse event with prior immunomodulatory treatment
- Stem cell transplant within 12 weeks prior to enrollment
- Active graft versus host disease other than Grade 1 skin involvement, or that requiring immunosuppressive treatment
- Requirement for systemic immune suppressive medication
- Active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, known HIV or AIDS related illness and SARS-CoV2
- Previous administration with an investigational drug within 4 weeks or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
- Known or suspected hypersensitivity to component of elranatamab (PF-06863135), murine and bovine products
- Live attenuated vaccine within 4 weeks
Sites / Locations
- Nagoya City University Hospital
- Japanese Red Cross Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Elranatamab (PF-06863135)
Arm Description
BCMA-CD3 bispecific antibody
Outcomes
Primary Outcome Measures
Number of Participants with Dose Limiting Toxicity (DLT)
Number of participants with DLTs, which are typically Grade 3 or higher adverse events
Secondary Outcome Measures
frequency of treatment-emergent adverse events
type and severity (including severity per NCI CTCAE v5)
frequency of laboratory abnormalities
complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)
Maximum plasma concentration (Cmax) of PF-06863135
Peak concentration of elranatamab (PF-06863135)
immunogenicity of PF-06863135
Incidence and titers of anti-drug antibodies and neutralizing antibodies against elranatamab (PF-06863135)
overall response rate
overall response rate (IMWG response criteria)
time to response
time to response (IMWG response criteria)
duration of response
duration of response (IMWG response criteria)
progression free survival
progression free survival (IMWG response criteria)
overall survival
overall survival
minimal residual disease
minimal residual disease (IMWG MRD criteria)
systemic soluble immune factors
pre and post dose quantification of soluble cytokines in serum
area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135
AUC of elranatamab (PF-06863135)
Trough serum concentrations of PF-06863135
Trough concentrations of (PF-06863135)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04798586
Brief Title
MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma
Official Title
A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETIC OF PF 06863135, A B CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
May 27, 2022 (Actual)
Study Completion Date
May 20, 2023 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to confirm the safety and tolerability of elranatamab (PF-06863135) in Japanese participants with relapsed or refractory MM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elranatamab (PF-06863135)
Arm Type
Experimental
Arm Description
BCMA-CD3 bispecific antibody
Intervention Type
Drug
Intervention Name(s)
Elranatamab (PF-06863135)
Intervention Description
BCMA-CD3 bispecific antibody
Primary Outcome Measure Information:
Title
Number of Participants with Dose Limiting Toxicity (DLT)
Description
Number of participants with DLTs, which are typically Grade 3 or higher adverse events
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
frequency of treatment-emergent adverse events
Description
type and severity (including severity per NCI CTCAE v5)
Time Frame
approximately 2 years
Title
frequency of laboratory abnormalities
Description
complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)
Time Frame
approximately 2 years
Title
Maximum plasma concentration (Cmax) of PF-06863135
Description
Peak concentration of elranatamab (PF-06863135)
Time Frame
4 weeks
Title
immunogenicity of PF-06863135
Description
Incidence and titers of anti-drug antibodies and neutralizing antibodies against elranatamab (PF-06863135)
Time Frame
approximately every 1 to 3 cycles (approximately 2 years)
Title
overall response rate
Description
overall response rate (IMWG response criteria)
Time Frame
approximately every 3 weeks for approximately 2 years
Title
time to response
Description
time to response (IMWG response criteria)
Time Frame
approximately every 3 weeks (approximately 2 years)
Title
duration of response
Description
duration of response (IMWG response criteria)
Time Frame
approximately every 3 weeks (approximately 2 years)
Title
progression free survival
Description
progression free survival (IMWG response criteria)
Time Frame
approximately every 3 weeks (approximately 2 years)
Title
overall survival
Description
overall survival
Time Frame
approximately every 3 months (approximately 2 years)
Title
minimal residual disease
Description
minimal residual disease (IMWG MRD criteria)
Time Frame
approximately 2 years
Title
systemic soluble immune factors
Description
pre and post dose quantification of soluble cytokines in serum
Time Frame
approximately 9 months
Title
area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135
Description
AUC of elranatamab (PF-06863135)
Time Frame
4 weeks
Title
Trough serum concentrations of PF-06863135
Description
Trough concentrations of (PF-06863135)
Time Frame
approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of multiple myeloma (IMWG criteria)
Measurable disease, as defined by at least 1 of the following
Serum myeloma (M) protein ≥0.5 g/dL (5 g/L)
Urine M protein ≥200 mg/24 h
Serum free light chain (FLC) >100 mg/L (10 mg/dL) with abnormal kappa:lambda ratio
Participants must have progressed on or been intolerant of at least 3 prior therapies including proteasome inhibitor, IMID drug and anti-CD38 antibody, either in combination or as a single agent
ECOG PS 0, 1 or 2. PS 3 is permitted if PS is due solely to bone pain
Adequate bone marrow, hematological, kidney and liver function
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1
Not pregnant and willing to use contraception
Exclusion Criteria:
POEMS syndrome
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
History of active autoimmune disorders
Any form of primary immunodeficiency
History of severe immune-mediated adverse event with prior immunomodulatory treatment
Stem cell transplant within 12 weeks prior to enrollment
Active graft versus host disease other than Grade 1 skin involvement, or that requiring immunosuppressive treatment
Requirement for systemic immune suppressive medication
Active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, known HIV or AIDS related illness and SARS-CoV2
Previous administration with an investigational drug within 4 weeks or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
Known or suspected hypersensitivity to component of elranatamab (PF-06863135), murine and bovine products
Live attenuated vaccine within 4 weeks
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
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
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=C1071002
Description
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MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma
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