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

NCT03567616 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-06-30

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Venetoclax

Tablet; oral

DRUG

Pomalidomide

Capsule; oral

DRUG

Dexamethasone

Administered orally; for participants over 75 years of age, dexamethasone could have been administered at a 20 mg dose \[qw\]

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • AbbVie

    lead INDUSTRY

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-18
Primary Completion
2020-06-18
Completion
2020-06-18
FDA Drug
Yes

Countries

  • United States
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03567616 on ClinicalTrials.gov