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A Phase 1 / 2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects With Relapsed or Refractory Multiple Myeloma

Status
Active
Cancer Type
Lymphoma
Multiple Myeloma
Trial Phase
Phase II
Eligibility
18 - 99 Years, Male and Female
Study Type
Treatment
NCD ID
NCT03314181
Protocol IDs
M15-654 (primary)
NCI-2018-00251
2017-002099-26
Study Sponsor
Abbvie

Summary

This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 2 distinct parts: Part 1 includes participants with t(11;14) positive relapsed / refractory (R / R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd); Part 2 includes participants with R / R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd). Each Part will be initiated with a dose-escalation phase. During the open-label, escalation phases, increasing doses of venetoclax with fixed doses of daratumumab and dexamethasone (Part 1a) or daratumumab, bortezomib, and dexamethasone (Part 2a) will be administered. The dose-escalation phases will be followed by either a randomized, and blinded (Part 1b) expansion phase or single-arm and open-label (Part 2b) expansion phase.
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