MLN9708 in Multiple Myeloma Not Treated with Stem Cell transplantation

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

• IRAS ID

  171524

• Contact name

  Martin Kaiser

• Contact email

  martin.kaiser@rmh.nhs.uk

• Sponsor organisation

  Millennium Pharmaceuticals, Inc.

• Eudract number

  2014-001394-13

• Duration of Study in the UK

  7 years, 4 months, 26 days

• Research summary

  The primary objective of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS), defined as the time from randomization to progressive disease (PD) or death from any cause, compared with placebo, in patients with newly diagnosed multiple myeloma (NDMM) who have had a major response, defined as complete response (CR), very good partial response (VGPR), or partial response(PR), to initial therapy and who have not undergone stem-cell transplantation (SCT).
  Patients will receive blinded ixazomib or matching placebo capsules (both hereafter referred to as “study drug”) orally on Days 1, 8, and 15 of every 28-day cycle. The starting dose will be 3 mg of study drug, which—if tolerated during the first 4 cycles—will be escalated to 4 mg beginning with Cycle 5 Day 1. The Treatment period will be approximately 24 months (equivalent to 26 cycles [if no cycle delays], to the nearest complete cycle) or until patients experience PD or unacceptable toxicity, whichever occurs first. Subsequent to the 24-month active Treatment period or removal from study therapy because of PD or toxicity, patients will be followed in the PFS, PD, progression free survival 2 (PFS2), and overall survival (OS) Follow-up periods for clinical status, disease status, subsequent therapies, health-related quality of life (HRQO)L, new primary malignancy, and survival.

  It is anticipated that this study will last for approximately 88 months (7.33 years), including a 28 month Enrolment period, a 24-month Treatment period, and an additional 36-month Follow-up period from the time at which the last patient has the opportunity to complete study therapy.

  Approximately 761 patients will be enrolled in this study from approximately 200 study centres globally

• REC name

  North East - York Research Ethics Committee

• REC reference

  15/NE/0167

• Date of REC Opinion

  14 Jul 2015

• REC opinion

  Further Information Favourable Opinion