Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants W… (NCT03145181) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
United States302 participantsStarted 2017-05-16
Plain-language summary
The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Documented diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
* Measurable multiple myeloma that is relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory multiple myeloma or be intolerant of those established multiple myeloma therapies, and a candidate for Teclistamab treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory drug and anti-CD38 monoclonal antibody in any order during the course of treatment. Participants who could not tolerate a proteasome inhibitor or immunomodulatory drugs and an anti-CD38 monoclonal antibody are allowed
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
* Female participants of childbearing potential must use acceptable method of contraception
* Participants must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease
Exclusion Criteria:
* Prior treatment with any B cell maturation antigen (BCMA) targeted therapy
* Prior antitumor therapy as follows, before the first dose of study drug: Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used…
What they're measuring
1
Dose Limiting Toxicity (DLT)
Timeframe: Up to Day 28
2
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability