CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 122 enrolled
Drug / intervention
Ixazomib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03170882
NCT03170882Phase 2Completed

A Phase 2, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

Millennium Pharmaceuticals, Inc.·interventional·Posted May 31, 2017·Updated Dec 20, 2022

In Brief

A Phase 2 clinical trial evaluating Ixazomib, Pomalidomide, and 1 other intervention for Relapsed and/or Refractory Multiple Myeloma. Completed, enrolled 122 participants across 111 sites in 18 countries.

Detailed Summary

The main aim of this study is to learn if ixazomib, given with dexamethasone, stops the cancer from getting worse in people with relapsed or refractory multiple myeloma. It will be compared to another medicine called pomalidomide, given with dexamethasone with people with the same condition. Relapsed means the previous cancer treatment stopped working, over time. Refractory means they did not respond to previous cancer treatment. Another aim is to check for side effects from the study medicines. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance. * Ixazomib capsules, given with dexamethasone tablets * Pomalidomide capsules, given with dexamethasone tablets All participants will take their study medicine on specific days during a 28-day cycle. The 1st dose of study medicines in each 28-day cycle will take place in the clinic, The other doses of the study medicines will be taken at home. This will happen for 6 cycles. After this, all study medicines will be taken at home. After treatment, participants will visit the clinic every 12 weeks for a check-up. If participants cannot attend their clinic for an important reason (for example, due to the COVID-19 pandemic), the clinic will make alternative arrangements using their local procedures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Norway, Russia, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 31, 2017
Enrollment StartAug 1, 2017
Primary CompletionAug 1, 2020
Study CompletionNov 26, 2021
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 9.1 years ago

Interventions

Ixazomibdrug

Ixazomib capsules

Pomalidomidedrug

Pomalidomide capsules

Dexamethasonedrug

Dexamethasone tablets