A Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT03785184
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • venetoclax — DRUG
    tablet; oral
  • lenalidomide — DRUG
    capsule; oral
  • dexamethasone — DRUG
    tablet; oral

Study Details

This study will evaluate the safety and preliminary efficacy of venetoclax when combined with lenalidomide and dexamethasone for participants with newly diagnosed, active t(11;14) positive multiple myeloma (MM). This study will consist of 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion.

Key Dates

Start date
Apr 29, 2019
Status verified
Aug 2019
Primary completion
Aug 22, 2019
Completion
Aug 22, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax + Lenalidomide + Dexamethasone
    Venetoclax up to 800 mg orally every day (QD) QD on Days 1 - 28 plus lenalidomide up to 25 mg orally QD on Days 1 - 21 (28 day cycle) plus dexamethasone up to 40 mg orally once weekly (QW).

Primary Outcome Measure

Percentage of Participates Who Achieve CR [ Time Frame: From baseline up to approximately 24 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope /ID# 212211DuarteCalifornia91010-
Marin Cancer Care /ID# 208476GreenbraeCalifornia94904-
University of California, Los Angeles /ID# 208516Los AngelesCalifornia90095-
Henry Ford Hospital /ID# 208481DetroitMichigan48202-
Karmanos Cancer Institute /ID# 208805DetroitMichigan48201-
Duke University Hospital /ID# 208306DurhamNorth Carolina27710-
UPMC Hillman Cancer Ctr /ID# 208121PittsburghPennsylvania15232-

Find similar trials in Duarte, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CAMarin Cancer Care· Greenbrae, CAUniversity of California, Los Angeles· Los Angeles, CAHenry Ford Hospital· Detroit, MIKarmanos Cancer Institute· Detroit, MIDuke University Hospital· Durham, NC

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