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

Phase 1

• Conditions: R/R Multiple Myeloma; MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004232-11-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-10
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male of female, at least 18 years old
• R/R MM with documented evidence of progression during or after the subject's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria
• Measurable disease, defined by at least 1 of the following disease activity criteria:
- serum M-protein = 1.0 g/dL (= 10 g/L) for immunoglobulin (Ig)G MM
- serum M-protein = 0.5 g/dL (= 5 g/L) for IgA, IgD, IgE, and IgM MM
- urine M-protein = 200 mg/24 hours
- serum-free light chain (FLC) = 10 mg/dL provided serum FLC ratio is abnormal
• Has received at least 1 prior line of therapy
• Must meet all of the following prior antimyeloma treatment parameters:
- subject must have received at least 2 consecutive cycles of lenalidomide or a lenalidomide-containing regimen
- subject must be refractory to lenalidomide
- subject must have been exposed to a proteasome inhibitor alone or in combination with another agent
- subject must have had a response of PR or better to prior therapy based on the investigator's determination of response as defined by IMWG criteria
• Has t(11;14) status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per central laboratory testing of a bone marrow aspirate sample 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
• (ECOG) performance status = 2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

• previous treatment with venetoclax or other BCL-2 inhibitors, or previous treatment with pomalidomide
• known sensitivity to any IMiDs
• allogenic or syngeneic stem cell transplant within 6 months before the first dose of study drug or active ongoing graft versus host disease
• autologous stem cell transplant within 12 weeks before the first dose of study drug
• known meningeal involvement of MM

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified