Study of PF 06863135 in Japanese Participants With Multiple Myeloma

JRCT ID: jRCT2021210002

Registered date:06/04/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Relapsed or Refractory Multiple Myeloma
• Date of first enrollment: 22/03/2021
• Target sample size: 6
• Study type: Interventional

Intervention(s)

Drug: PF-06863135
BCMA-CD3 bispecific antibody

Outcome(s)

Primary Outcome

Primary Outcome Measures :
1.Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: up to 28 days ]

Secondary Outcome

Secondary Outcome Measures :
1.frequency of treatment-emergent adverse events [ Time Frame: approximately 2 years ]
2.frequency of laboratory abnormalities [ Time Frame: approximately 2 years ]
3.Maximum plasma concentration (Cmax) of PF-06863135 [ Time Frame: 4 weeks ]
4.immunogenicity of PF-06863135 [ Time Frame: approximately every 1 to 3 cycles (approximately 2 years) ]
5.overall response rate [ Time Frame: approximately every 3 weeks for approximately 2 years ]
6.time to response [ Time Frame: approximately every 3 weeks (approximately 2 years) ]
7.duration of response [ Time Frame: approximately every 3 weeks (approximately 2 years) ]
8.progression free survival [ Time Frame: approximately every 3 weeks (approximately 2 years) ]
9.overall survival [ Time Frame: approximately every 3 months (approximately 2 years) ]
10.minimal residual disease [ Time Frame: approximately 2 years ]
11.systemic soluble immune factors [ Time Frame: approximately 9 months ]
12.area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135 [ Time Frame: 4 weeks ]
13.Trough serum concentrations of PF-06863135 [ Time Frame: approximately 2 years ]

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Inclusion Criteria:
*Diagnosis of multiple myeloma (IMWG criteria)
*Measurable disease, as defined by at least 1 of the following
1.Serum myeloma (M) protein >=0.5 g/dL (5 g/L)
2.Urine M protein >=200 mg/24 h
3.Serum free light chain (FLC) >100 mg/L (10 mg/dL) with abnormal kappa:lambda ratio
*Participants must have progressed on or been intolerant of at least 3 prior therapies including proteasome inhibitor, IMID drug and anti-CD38 antibody, either in combination or as a single agent
*ECOG PS 0, 1 or 2. PS 3 is permitted if PS is due solely to bone pain
*Adequate bone marrow, kidney and liver function
*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:
*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
*Major surgery within 4 weeks prior to study entry
*Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
*Radiation therapy within 2 weeks prior to study entry
*History of active autoimmune disorders
*Any form of primary immunodeficiency
*History of severe immune-mediated adverse event with prior immunomodulatory treatment
*Active graft versus host disease other than Grade 1 skin involvement, or that requiring immunosuppressive treatment
*Requirement for systemic immune suppressive medication
*Participant known to be refractory to platelet or red blood cell transfusions
*Current requirement for chronic blood product support
*Active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, known HIV or AIDS related illness and SARS-CoV2
*Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
*Clinically significant cardiovascular in the previous 6 months
*Hypertension that cannot be controlled by medications
*Previous administration with an investigational drug within 4 weeks or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
*Known or suspected hypersensitivity to component of PF 06863135, murine and bovine products

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT04798586