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IPD in RRMM Characterized with Genomic Abnormalities of Adverse Prognostic

NCT03683277 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-02-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • AXONAL

    collaborator UNKNOWN

  • Nantes University Hospital

    collaborator OTHER

  • University Hospital, Grenoble

    collaborator OTHER

  • Euraxi Pharma

    collaborator INDUSTRY

  • QPS Holdings LLC

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Takeda

    collaborator INDUSTRY

  • Intergroupe Francophone du Myelome

    lead NETWORK

Principal Investigators

  • Xavier LELEU, Pr · Poitiers University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-03
Primary Completion
2022-12-31
Completion
2023-02-10

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03683277 on ClinicalTrials.gov