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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active Not-enrolling
China
for more information at clinicaltrials.gov
EXPERIMENTAL: Elranatamab
BCMA-CD3 bispecific antibody
DRUG: Elranatamab
BCMA-CD3 bispecific antibody
Not pregnant and willing to use contraception
Phase 1b: Number of participants with dose-limiting toxicities (DLT)
Number of participants with DLTs
Up to 4 weeks
Phase 2: Objective response rate
Objective response rate (IMWG response criteria)
Up to approximately 2 years
Duration of response
Duration of response (IMWG response criteria)
Up to approximately 2 years
Cumulative complete response rate
Cumulative complete response rate (IMWG response criteria)
Up to approximately 2 years
Duration of cumulative complete response
Duration of cumulative complete response (IMWG response criteria)
Up to approximately 2 years
Progression free survival
Progression free survival (IMWG response criteria)
Up to approximately 2 years
Overall survival (OS)
Up to approximately 2 years
Time to response (TTR)
Time to response (IMWG response criteria)
Up to approximately 2 years
Minimal residual disease negativity rate
Minimal residual disease negativity rate (IMWG response criteria)
Up to approximately 2 years
Frequency of treatment-emergent adverse events
Type and severity (including severity per NCI CTCAE v5)
Up to approximately 2 years
Frequency of laboratory abnormalities
Complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)
Up to approximately 2 years
Serum Concentration of Elranatamab (PF-06863135)
Serum concentrations of Elranatamab (PF-06863135) will be reported.
Up to approximately 2 years
Immunogenicity of elranatamab (PF-06863135)
Immunogenicity of elranatamab (anti-drug antibodies against elranatamab)
Up to approximately 2 years
Change from Baseline in Patient-Reported Outcomes as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)
The QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale.
Up to approximately 2 years
Change from Baseline in Patient-Reported Outcomes as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire myeloma-specific module (EORTC QLQ-MY20)
The EORTC MY20 is a myeloma-specific module to assess quality of life in patients with multiple myeloma. It contains 20 items which can be grouped into a disease symptom subscale (6 items), side effects of treatment subscale (10 items), body image (1 item) and future perspective subscale (3 items)
Up to approximately 2 years
Change from Baseline in Patient-Reported Outcomes as Assessed by EuroQol Five Dimension Questionnaire (EQ-5D)
The EQ-5D is a 6-item patient-completed questionnaire designed to assess health status in terms of a single index value or utility score. There are 2 components, a Health State Profile which has individuals rate their level of problems in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a VAS in which patients rate their overall health status from 0 (worst imaginable) to 100 (best imaginable).
Up to approximately 2 years
Change from Baseline in Patient-Reported Outcomes as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ CIPN20)
The EORTC QLQ CIPN20 is a module developed to assess chemotherapy-induced peripheral neuropathy. It contains 20 items which can be grouped into a sensory subscale (9 items), motor subscale (8 items) and autonomic subscale (3 items).
Up to approximately 2 years
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Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: