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

JRCT ID: jRCT2031210228

Registered date:06/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: relapsed/refractory multiple myeloma
• Date of first enrollment: 11/08/2021
• Target sample size: 150
• Countries of recruitment: Australia,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: PF-06863135
BCMA-CD3 bispecific antibody

Outcome(s)

Primary Outcome

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

Secondary Outcome

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 ]

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
*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

Exclude 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)

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT04649359