PHI/II Study MLN9708 with Melphalan & Prednisone in Multiple Myeloma

• Research type

  Research Study

• Full title

  An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of MLN9708, a Next-Generation Proteasome Inhibitor, Administered in Combination With a Standard Care Regimen of Melphalan and Prednisone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment

• IRAS ID

  77359

• Contact name

  Jamie D Cavenagh

• Sponsor organisation

  Millenium Pharmacueticals Inc

• Eudract number

  2010-023772-71

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  Phase I/II open-label study of oral MLN9708 (study drug) added to standard care treatment of Melphalan and Prednisone (or MP) in patients who have been newly diagnosed with multiple myeloma and are not eligible for high-dose theraphy plus stem cell transplantation, because they are =65y old or have coexisting conditions and, for whom, standard MP treatment is indicated. Phase I of the study will determine the safety, maximum tollerated dose (MTD) and Phase II recommended dose of study drug when added to MP treatment. Phase II will evaluate the efficacy and safety of MLN9708 added to MP using Simon's 2-stage design. In both phases MLN9708 will be tested on a twice-weekly (arm A) and once-weekly (arm B) schedule, enrolling up to 60 patients (30 each arm) in Phase I and up to 104 (52 each arm) in Phase II. In phase 1 patients will be assigned to a treatment arm by the investigator according to instructions from the sponsor. In phase 2 patients will be randomized to treatment. Each phase of the study will consist of a screening period, a treatment -induction period followed by a treatment-maintenance period, an end of study and follow-ups period. At the end of the induction period, patients whom disease is stable or responding to treatment will enter the maintenance period (up to 12 cycles, each lasting 28 days) where they will only take MLN9708 once a week at the same doses tolerated on the induction period. Their response to treatment will be assessed every 2 cycles. Patient who stop treatment (either than for PD - progession disease) will continue having PFS (progression free survival)follow-up visits every 16 weeks from end of treatment until PD or start antineoplastic therapy. Patients who stop treatment due to PD will have Overall Survival visits every 12 weeks from PD or start antineoplastic therapy

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  11/NW/0597

• Date of REC Opinion

  24 Nov 2011

• REC opinion

  Further Information Favourable Opinion