C16029: Phase 2/3 Randomized, Open-Label Study in Multiple Myeloma
Research type
Research Study
Full title
A Phase 2/3, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
IRAS ID
228365
Contact name
Rachel Hall
Contact email
Sponsor organisation
Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda
Eudract number
2016-004742-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The main objectives of this clinical study is to compare the effect of the investigational combination of Ixazomib + Dexamethasone versus Pomalidomide + Dexamethasone on progression-free survival (PFS) in patients with relapsed and/or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy, including lenalidomide and a proteasome inhibitor, and are refractory to lenalidomide but not refractory to proteasome inhibitors.
This is a randomised, open-label study. Both the participant and study doctor will know which study medications they are taking throughout the study. Participants will be selected by chance to receive one of the following treatment arms:
Ixazomib+Dexamethasone (ixa+dex; Arm A) or
Pomalidomide+Dexamethasone (pom+dex; Arm B)
The treatment period is divided into “cycles” and each cycle is planned to last 28 days. Patients will come into the clinic at least once per cycle, and more often at the start of the treatment. Patients will attend an end of treatment visit 30 days after receiving their last dose of study therapy and follow-up will continue through the follow-up period.
The study involves procedures such as: medical history, physical exams, questionnaires, status assessments, blood and urine tests, ECG (measures heart rhythm), vital signs, bone marrow biopsy or aspirate, diary completion. Participants may have some of the following: x-rays, CT, PET-CT, or MRI and it is possible additional procedures may be required.
Millennium Pharmaceuticals Inc. is sponsoring this trial and it is expected that approximately 300 patients will take part from 100 sites worldwide. The study is expected to last up to 63 months (5 years, 3 months). If interested, please speak to your doctor.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0546
Date of REC Opinion
15 Nov 2017
REC opinion
Further Information Favourable Opinion