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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

AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF 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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031210228
Enrollment
150
Registered
2021-08-06
Start date
2021-08-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

relapsed/refractory multiple myeloma

Interventions

Drug: PF-06863135 BCMA-CD3 bispecific antibody

Sponsors

Kawai Norisuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
Primary Outcome Measures : 1.objective response rate [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]

Secondary

MeasureTime frame
Secondary Outcome Measures : 1.duration of response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ] 2.cumulative complete response rate [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ] 3.duration of cumulative complete response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ] 4.progression free survival [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ] 5.time to response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ] 6.minimal residual disease negativity rate [ Time Frame: assessed approximately every 12 months [up to approximately 2 years] ] 7.frequency of treatment-emergent adverse events [ Time Frame: up to approximately 2 years ] 8.frequency of laboratory abnormalities [ Time Frame: assessed at least approximately every cycle [each cycle approximately 28 days] ] 9.concentrations of PF-0683135 [ Time Frame: assessed approximately every 1 to 3 cycles [each cycle approximately 28 days] ] 10.immunogenicity of PF-0683135 [ Time Frame: assessed approximately every 1 to 3 cycles [each cycle approximately 28 days] ] 11.overall survival [ Time Frame: at least approximately 2 years ]

Countries

Australia, Belgium, Canada, France, Germany, Japan, Poland, Spain, United Kingdom, United States

Contacts

Public ContactClinical Trials Information Desk

Pfizer R&D Japan G.K.

clinical-trials@pfizer.com+81-3-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026