ADMYRE: Aplidin – Dexamethasone in RElapsed/Refractory MYeloma

• Research type

  Research Study

• Full title

  Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination with Dexamethasone vs. Dexamethasone Alone in Patients with Relapsed/Refractory Multiple Myeloma.

• IRAS ID

  48769

• Contact name

  Heather Oakervee

• Contact email

  heather.oakervee@bartshealth.nhs.uk

• Sponsor organisation

  PharmaMar S.A.

• Eudract number

  2009-016138-29

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Approximately 40-80 sites worldwide will participate in a prospective, open-label, two-arm, 2:1 randomized phase III study. The efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone will be studied by means of Progression Free Survival (PFS) calculated using the International Myeloma Working Group (IMWG) uniform response criteria, and by the evaluation of the secondary endpoints (duration of response, overall survival, efficacy in patients who undergo crossover, safety profile, PK). Approximately 250 patients will be included in the study; they will be assigned to the two treatment arms as follows:- Arm A (plitidepsin痬媙櫊): 167 patients.- Arm B (dexamethasone alone): 83 patients. An early futility analysis will be performed with the data collected when 40 patients in arm A are evaluable for response. A response rate of at least 30% (twelve or more responses by IRC review) will be taken as threshold for continuation of the study. Patients in the control arm (dexamethasone alone, Arm B) who have documented disease progression according to Investigator's criteria, after a minimum of eight weeks from randomization, should be offered crossover to the combination arm (plitidepsin dexamethasone, Arm A) upon Sponsor agreement. An Independent Review Committee (IRC) consisting of medical specialists directly involved in the care of patients with MM but not taking part in this trial as investigators or sub investigators, will review all efficacy data and will assign the date of progression/censoring and objective response according to their independent evaluation. This IRC will be blinded regarding to treatment arm allocation and identity of the cases reviewed. An Independent Data Monitoring Committee (IDMC), including specialists in MM, will evaluate the results of the protocol-specified analyses performed by an independent statistician, including investigators and IRC efficacy assessments and safety information. Then, the IDMC will provide advice on the conduct of the study.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  10/H0406/27

• Date of REC Opinion

  30 Apr 2010

• REC opinion

  Further Information Favourable Opinion