Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

Phase 1

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

• Registration Number: EUCTR2016-004742-28-ES
• Lead Sponsor: Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-21
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Adult patients (aged =18 years) who have been diagnosed with multiple myeloma (MM) according to standard criteria.
All patients must have had a relapse or PD after having received 2 or more prior lines of systemic therapy. (A line of therapy is defined as 1 or more cycles of a planned treatment program; this may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. For example, a planned treatment approach of induction therapy followed by autologous stem-cell transplantation, followed by maintenance is considered 1 line of therapy. Typically each line of therapy is separated by PD.)
All patients must be refractory to lenalidomide, defined as having received at least 2 consecutive cycles of lenalidomide as a single agent or within a lenalidomide-containing regimen and having had PD during treatment with or within 60 days after the last dose of lenalidomide. The starting dose of lenalidomide should have been 25 mg (or as low as 10 mg in the case of renal function impairment or other safety concern), and the final dose should
have been a minimum of 10 mg.
All patients must have received at least 2 consecutive cycles of a bortezomib- or carfilzomib-containing regimen, and either:
– Achieved at least a partial response (PR) and did not have PD during treatment with or within 60 days after the last dose of bortezomib or carfilzomib, OR
– Had bortezomib and/or carfilzomib intolerance (defined as discontinuation because of drug-related adverse events (AEs) before completion of the planned treatment course) without PD upon the start of the next regimen.
All patients must have an Eastern Cooperative Oncology Group score of 0 to 2.
All patients must have measurable disease defined by serum M-protein =1 g/dL (=10 g/L) or urine M-protein =200 mg/24 hours and must have documented MM isotype by immunofixation (central laboratory).
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

Patients must not have received prior ixazomib or pomalidomide and must not have participated in a previous ixazomib clinical study.

Study & Design

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