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A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant

NCT02181413 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 656

Last updated 2024-11-19

Study results available
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Summary

The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response \[CR\], very good partial response \[VGPR\], or partial response \[PR\]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).

Conditions

Interventions

DRUG

Ixazomib Citrate

Ixazomib citrate capsules

DRUG

Placebo

Ixazomib citrate placebo-matching capsules

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-16
Primary Completion
2018-04-16
Completion
2023-09-08
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT02181413 on ClinicalTrials.gov