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

JRCT ID: jRCT2051210103

Registered date:11/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: relapsed/refractory multiple myeloma
• Date of first enrollment: 19/11/2021
• Target sample size: 76
• Study type: Interventional

Intervention(s)

Drug: PF-06863135
BCMA-CD3 bispecific antibody

Outcome(s)

Primary Outcome

Primary Outcome Measures :
1.Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) [ Time Frame: Cycle 1 (28 days) ]

Secondary Outcome

Secondary Outcome Measures :
1.Incidence of Dose Limiting Toxicities [ Time Frame: Cycle 2 (28 days) ]
2.Frequency of Adverse Events [ Time Frame: Up to 90 days after last dose and for approximately 2 years ]
3.Frequency of laboratory abnormalities [ Time Frame: Assessed at every cycles [each cycle approximately 28 days] ]
4.Objective response rate [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]
5.Cumulative Complete Response Rate [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]
6.Time to response [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]
7.Duration of response [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]
8.Duration of cumulative complete response rate [ Time Frame: Assessed approximately every 28 days and for approximately 2 years ]
9.Progression Free Survival [ Time Frame: Assessed approximately every 28 days for approximately 2 years ]
10.Overall Survival [ Time Frame: Approximately 2 years ]
11.Minimal Residual Disease negativity rate [ Time Frame: Assessed approximately every 12 months and for approximately 2 years ]
12.Pre- and postdose concentrations of PF-06863135 [ Time Frame: Assessed approximately every 1 to 3 cycles [cycle of approximately 28 days] ]
13.Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against PF-06863135 [ Time Frame: Assessed approximately every 1 to 6 cycles [cycle of approximately 28 days] ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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)

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT05014412