Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This study is designed to evaluate the safety and preliminary efficacy of venetoclax combined with pomalidomide and dexamethasone in subjects with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least 1 prior line of therapy. The study will consist of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). For Part 2 the subjects will be divided into 2 cohorts, subjects positive for t(11;14) translocation and subjects negative for t(11;14) translocation.

Official Title

A Phase 2, Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Keywords

Multiple Myeloma Cancer Multiple Myeloma (MM) Relapsed or Refractory (R/R) venetoclax pomalidomide dexamethasone Neoplasms, Plasma Cell Dexamethasone acetate Thalidomide BB 1101

Eligibility

You can join if…

Open to people ages 18 years and up

  • Relapsed or refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the subject's last treatment regimen.
  • Measurable disease as described in the protocol.
  • Received at least 1 prior line of therapy, as described in the protocol.
  • Must meet prior antimyeloma treatment parameters, as described in the protocol, and includes:
  • Received at least 2 consecutive cycles of lenalidomide or a lenalidomide containing regimen
  • Refractory to lenalidomide
  • Exposed to a proteasome inhibitor (PI) alone or in combination with another agent.
  • Had a response of partial response (PR) or better to prior therapy based on the investigator's determination of response as defined by International Myeloma Working Group (IMWG) criteria.
  • Has t(11;14) status as described in the protocol and meets the following criteria:
  • For Part 1: MM subjects independent of cytogenetic profile.
  • For Part 2, Arm A: subject must be t(11;14) positive.
  • For Part 2, Arm B: subject must be t(11;14) negative.
  • An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Adequate kidney, liver and hematologic laboratory values.

You CAN'T join if...

  • History of severe osteoporosis with previous spontaneous fractures.
  • Untreated brain or meningeal metastases.
  • Grade 2 or higher peripheral neuropathy (only applies to subjects who would receive taxane therapy).
  • Unresolved Grade 2 or higher toxicities related to previous anticancer therapy.
  • Known active infection of hepatitis B or C, or human immunodeficiency virus.
  • Recent history (within 6 months) of congestive heart failure, ischemic cardiovascular event, pericardial effusion, or pericarditis.
  • Subject used medications including investigational drugs, steroids, cytochrome P450(CYP)3A inhibitors, or live vaccines within the time frames as described in the protocol.

Locations

  • Univ California, San Francisco /ID# 204524 not yet accepting patients
    San Francisco California 94143-2204 United States
  • Oregon Health and Science University /ID# 205582 not yet accepting patients
    Portland Oregon 97239-3098 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03567616
Phase
Phase 2
Study Type
Interventional
Last Updated