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IPD in RRMM Characterized With Genomic Abnormalities of Adverse Prognostic — IFM2014-01  

Multiple Myeloma Clinical Trial

Official title:
Multicenter Open Label Phase 2 Single Arm Study of Ixazomib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Characterized With Genomic Abnormalities of Adverse Adverse Prognostic

Clinical Trial Summary

This study is a Multicenter, Open-label, Phase II study of ixazomib, plus Pomalidomide and Dexamethasone regimen (IPD) in RRMM with adverse Genomic Abnormalities.

Clinical Trial Description

There is no escalation dose study, the maximum tolerated dose has already been determined in previous phase 1 escalation dose studies. The proposed dose of dexamethasone is considered standard. Patients will receive the IPd regimen until progression. The hypothesis is that this IPd regimen based combination will eventually improve time to disease progression, with no additional toxicity, as compared to other available regimens, in this subgroup of patients with myeloma characterized with a very adverse prognosis. Study design. This trial will study the efficacy and safety of IPd regimen in Relapsed and Refractory Multiple Myeloma with adverse Genomic Abnormalities until progression in 2 separate phases. - Induction phase: 17 cycles - 21-days cycles Ixazomib 3 mg D1, D4, D8 and D11 Pomalidomide 4mg D1 to D14 Dexamethasone 40 mg/d D1, D8 and D15 if patient aged <75 years Dexamethasone 20 mg/d D1, D8 and D15 if patient aged ≥ 75 years - Maintenance phase: until progression - 28-days cycles Ixazomib 4mg D1, D8 and D15 Pomalidomide 4mg D1 to D21 - It is not planned for the patients to receive autologous stem-cell transplantation as part of the study trial ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03683277
Study type Interventional
Source Intergroupe Francophone du Myelome
Contact
Status Terminated
Phase Phase 2
Start date November 3, 2019
Completion date February 10, 2023
View Details
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