Description:
The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can
provide clinical benefit in participants with relapsed/refractory multiple myeloma.
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.
Title
- Brief Title: MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb
- Official Title: MAGNETISMM-3 AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY
Clinical Trial IDs
- ORG STUDY ID:
C1071003
- SECONDARY ID:
2020-004533-21
- SECONDARY ID:
MagnetisMM-3
- NCT ID:
NCT04649359
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Elranatamab (PF-06863135) | | Elranatamab (cohort A) |
Purpose
The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can
provide clinical benefit in participants with relapsed/refractory multiple myeloma.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Elranatamab (cohort A) | Experimental | BCMA-CD3 bispecific antibody | - Elranatamab (PF-06863135)
|
Elranatamab (cohort B) | Experimental | BCMA-CD3 bispecific antibody | - Elranatamab (PF-06863135)
|
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:
1. Serum M-protein >0.5 g/dL by SPEP
2. Urinary M-protein excretion >200 mg/24 hours by UPEP
3. 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
- Cohort A: has not received prior BCMA-directed therapy
- Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)
- ECOG performance status ≤2
- 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
- Amyloidosis
- POEMS syndrome
- Stem cell transplant within 12 weeks prior to enrollment
- 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.
- 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)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | objective response rate |
Time Frame: | assessed approximately every 4 weeks [up to approximately 2 years] |
Safety Issue: | |
Description: | objective response rate (IMWG response criteria) |
Secondary Outcome Measures
Measure: | duration of response |
Time Frame: | assessed approximately every 4 weeks [up to approximately 2 years] |
Safety Issue: | |
Description: | duration of response (IMWG response criteria) |
Measure: | cumulative complete response rate |
Time Frame: | assessed approximately every 4 weeks [up to approximately 2 years] |
Safety Issue: | |
Description: | cumulative complete response rate (IMWG response criteria) |
Measure: | duration of cumulative complete response |
Time Frame: | assessed approximately every 4 weeks [up to approximately 2 years] |
Safety Issue: | |
Description: | duration of cumulative complete response (IMWG response criteria) |
Measure: | progression free survival |
Time Frame: | assessed approximately every 4 weeks [up to approximately 2 years] |
Safety Issue: | |
Description: | progression free survival (IMWG response criteria) |
Measure: | time to response |
Time Frame: | assessed approximately every 4 weeks [up to approximately 2 years] |
Safety Issue: | |
Description: | time to response (IMWG response criteria) |
Measure: | minimal residual disease negativity rate |
Time Frame: | assessed approximately every 12 months [up to approximately 2 years] |
Safety Issue: | |
Description: | minimal residual disease negativity rate (IMWG response criteria) |
Measure: | frequency of treatment-emergent adverse events |
Time Frame: | up to approximately 2 years |
Safety Issue: | |
Description: | type and severity (including severity per NCI CTCAE v5) |
Measure: | frequency of laboratory abnormalities |
Time Frame: | assessed at least approximately every cycle [each cycle approximately 28 days] |
Safety Issue: | |
Description: | complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5) |
Measure: | concentrations of elranatamab (PF-06863135) |
Time Frame: | assessed approximately every 1 to 3 cycles [each cycle approximately 28 days] |
Safety Issue: | |
Description: | pharmacokinetics of elranatamab |
Measure: | immunogenicity of elranatamab (PF-06863135) |
Time Frame: | assessed approximately every 1 to 3 cycles [each cycle approximately 28 days] |
Safety Issue: | |
Description: | immunogenicity of elranatamab (anti-drug antibodies against elranatamab) |
Measure: | overall survival |
Time Frame: | at least approximately 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Pfizer |
Trial Keywords
- Myeloma
- Multiple Myeloma
- relapsed Multiple Myeloma
- refractory Multiple Myeloma
- PF-06863135
- BCMA
- bispecific
- bispecific antibody
- BCMA-CD3 bispecific
- Elranatamab
- MagnetisMM-3
Last Updated
August 18, 2021