A Phase 3 interventional study of Perifosine and Perifosine Placebo in Multiple Myeloma, sponsored by AEterna Zentaris. Terminated at 88 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-09.
Sponsored by AEterna Zentaris · Phase 3, Interventional, and Treatment
This is a randomized Phase III study to evaluate the efficacy and safety of perifosine when added to the combination of bortezomib and dexamethasone in multiple myeloma patients who have relapsed on a prior bortezomib treatment regimen.
A pre-planned interim analysis is expected to take place in Q1 of 2013.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 135 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →AEterna Zentaris is the lead sponsor of 34 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Perifosine added to the combination of Bortezomib and Dexamethasone. Perifosine is is supplied as a film-coated tablet containing 50 mg of active ingredient. Perifosine will be administered orally on an outpatient basis throughout the study. Daily administration will be one 50 mg tablet. The first dose of perifosine should be taken on the same day that bortezomib and dexamethasone are administered (Cycle 1 Day 1).
Drug: Perifosine · Drug: Bortezomib · Drug: Dexamethasone
Perifosine placebo added to the combination of Bortezomib and Dexamethasone. The placebo for perifosine is provided in 256 mg white to off-white, round, biconvex film-coated tablets to permit a blinded trial with perifosine 50 mg film coated tablets. Placebo will be administered orally on an outpatient basis throughout the study. Daily administration will be one perifosine placebo tablet. The first dose of placebo should be taken on the same day that bortezomib and dexamethasone are administered (Cycle 1 Day 1).
Drug: Perifosine Placebo · Drug: Bortezomib · Drug: Dexamethasone
Perifosine will be dosed as one 50 mg pill every day of each cycle.
Also known as: D-21266, KRX-0401
Perifosine placebo will be dosed as one 50 mg pill every day of each cycle.
Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Determine the PFS (progression free survival) in patients with multiple myeloma, treated with perifosine, bortezomib and dexamethasone compared to patients treated with placebo, bortezomib and dexamethasone
Progression-free survival will be defined as the time between randomization and the date of progression that occurred during the Core Phase.
Time frame: 6 - 24 months
Overall survival (OS)
OS is defined as time from randomization to death from any cause during the Core Phase of the study.
Time frame: Up to 24 months
Overall response rate (ORR)
The ORR for each treatment arm will be estimated as the proportion of responders, defined as a patient whose best overall response is PR or better during the treatment period, using criteria prospectively established.
Time frame: 6 - 24 months
Adverse Events
Each AE and SAE term submitted will be mapped to a preferred term (PT) using the MedDRA dictionary. The investigator will classify the severity of AEs using the NCI CTCAE v3.0 and will assess the relationship of each event to each study treatment.
Time frame: Up to 24 months
This study is terminated, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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AEterna Zentaris