MagnetisMM-9: Study of PF-06863135 Monotherapy in Participants With Relapsed/Refractory Multiple Myeloma

Phase 2

• Conditions: relapsed/refractory multiple myeloma

• Registration Number: JPRN-jRCT2051210103
• Lead Sponsor: Kawai Norisuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 76

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
*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

Exclusion Criteria:
*Smoldering multiple myeloma
*Active Plasma cell leukemia
*POEMS syndrome
*Amyloidosis
*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
*Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment
*Ongoing Grade >=2 peripheral sensory or motor neuropathy.
*History of any grade peripheral sensory or motor neuropathy with prior BCMA-directed therapy.
*History of GBS or GBS variants, or history of any Grade >=3 peripheral motor polyneuropathy.
*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 treatment with an anti-BCMA bispecific antibody.
*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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified