NCT03683277

IPD in RRMM Characterized With Genomic Abnormalities of Adverse Prognostic

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Intergroupe Francophone du Myelome · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Multiple Myeloma
• Relapsed and Refractory Multiple Myeloma
• Genetic Condition

Interventions

Type	Name	Description
DRUG	Ixazomib/Pomalidomide/Dexamethasone	Treatment with association of Ixazomib, Pomalidomide and Dexamethasone (IPD) Induction phase : 21-days cycles - maximum of 17 cycles Ixazomib (tablets) 3 mg D1, D4, D8 and D11 Pomalidomide (tablets) 4mg D1 to D14 Dexamethasone (tablets) 40 mg/d D1, D8 and D15 if patient aged \<75 years Dexamethasone (tablets) 20 mg/d D1, D8 and D15 if patient aged ≥ 75 years Treatment with association of Ixazomib and Pomalidomide (IP) Maintenance phase : 28-days cycles until disease progression Ixazomib (tablets) 4mg D1, D8 and D15 Pomalidomide (tablets) 4mg D1 to D21

Timeline

• Start date: 2019-11-03
• Primary completion: 2022-12-31
• Completion: 2023-02-10
• First posted: 2018-09-25
• Last updated: 2025-02-19

Locations

28 sites across 1 country: France