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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
135
Perifosine will be dosed as one 50 mg pill every day of each cycle.
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.
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Unnamed facility
La Verne, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
San Pablo, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Boulder, Colorado, United States
Unnamed facility
Colorado Springs, Colorado, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Lakewood, Colorado, United States
Unnamed facility
Littleton, Colorado, United States
Unnamed facility
Longmont, Colorado, United States
...and 76 more locations