The drug being tested in this study is called TAK-079. TAK-079 is being tested to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) when added to 1 of 2 standard backbone regimens (LenDex or VRd) with newly diagnosed NDMM for whom stem cell transplantation (SCT) is not planned as initial therapy. The study will enroll approximately 36 participants. Participants will be non-randomly assigned to one of the two treatment groups: - TAK-079 and LenDex - TAK-079 and VRd This multi-center trial will be conducted in the United States. The overall time to participate in this study is 36 months. Participants will have a follow-up visit 30 days after the last dose of study drug or before the start of subsequent alternative anticancer therapy, to permit the detection of any delayed AEs.
SparkCures ID | 1022 |
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Trial Phase | Phase 1 |
Enrollment | 36 Patients |
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The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Inclusion Criteria:
Exclusion Criteria:
NOTE: Prophylactic localized ("spot") radiation for areas of pain is allowed.
The following is a listing of trial locations that are open and accepting patients.
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Bethesda, MD
Cincinnati, OH
Bethesda, MD
Cincinnati, OH
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