A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Columbus, Georgia.

Sponsor
AbbVie
Study ID
NCT03567616
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Tablet; oral
  • Pomalidomide — DRUG
    Capsule; oral
  • Dexamethasone — DRUG
    Administered orally; for participants over 75 years of age, dexamethasone could have been administered at a 20 mg dose \[qw\]

Study Details

This was an open-label, multicenter study designed to evaluate the safety and preliminary efficacy of venetoclax combined with pomalidomide and dexamethasone in participants with relapsed or refractory (R/R) multiple myeloma (MM) who received at least 1 prior line of therapy with documented evidence of progression during or after the participant's last treatment regimen. The study was designed to consist of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). For Part 2 the participants were to be divided into 2 cohorts, participants positive for t(11;14) translocation and participants negative for t(11;14) translocation.

Key Dates

Start date
Oct 18, 2018
Status verified
Jun 2021
Primary completion
Jun 18, 2020
Completion
Jun 18, 2020

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation
    Venetoclax (400 mg oral \[PO\], once daily \[QD\]) administered with pomalidomide (4 mg PO, QD) and dexamethasone (40 mg once weekly \[qw\]) in 28-day cycles until documented disease progression, documented unacceptable toxicity, withdrawal of consent, or the participant met other criteria for discontinuation per study protocol
  • Experimental: Part 2: Dose Expansion, t(11;14) positive
    Participants positive for t(11;14) translocation were to receive the venetoclax dose determined to be safe in Part 1 as well as pomalidomide (4 mg oral \[PO\], once daily \[QD\]) and dexamethasone (40 mg once weekly \[qw\])
  • Experimental: Part 2: Dose Expansion, t(11;14) negative
    Participants negative for t(11;14) translocation were to receive the venetoclax dose determined to be safe in Part 1 as well as pomalidomide (4 mg oral \[PO\], once daily \[QD\]) and dexamethasone (40 mg once weekly \[qw\])

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: From first dose of study drug until 30 days following last dose of study drug (up to 70 weeks) ]

Locations (5)

FacilityCityStateZIPSite coordinators
John B. Amos Cancer Center - C /ID# 202055ColumbusGeorgia31904-
University of Kansas Cancer Center /ID# 201292FairwayKansas66205-2528-
Washington University-School of Medicine /ID# 201287St LouisMissouri63110-
Duke University Hospital /ID# 200805DurhamNorth Carolina27710-
Ohio State Cancer Center /ID# 202443ColumbusOhio43210-

Find similar trials in Columbus, GA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
John B. Amos Cancer Center - C· Columbus, GAUniversity of Kansas Cancer Center· Fairway, KSWashington University-School of Medicine· St Louis, MODuke University Hospital· Durham, NCOhio State Cancer Center· Columbus, OH

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