Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Relapsed multiple myeloma, Refractory multiple myeloma, Relapsed refractory multiple myeloma
Brief summary
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.
Detailed description
A pre-planned interim analysis is expected to take place in Q1 of 2013.
Interventions
Perifosine placebo will be dosed as one 50 mg pill every day of each cycle.
DRUGBortezomib
Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
DRUGPerifosine
Perifosine will be dosed as one 50 mg pill every day of each cycle.
DRUGDexamethasone
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Sponsors
Dana-Farber Cancer Institute
AEterna Zentaris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient was previously diagnosed with multiple myeloma based on standard diagnostic criteria. * Patients must have relapsed (progressed \> 60 days) after their last dose of bortezomib-based therapy. In addition, patients may be relapsed or refractory to other non-bortezomib-based therapies. * Patient has received at least 1 but not more than 4 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen. * Patients must have adequate organ and marrow function.
Exclusion criteria
* Patients must not be refractory to any bortezomib-containing regimen. * History of allergic reactions or intolerance attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine), bortezomib or dexamethasone or any of their components. * Prior treatment with perifosine or an investigational proteasome inhibitor. * Chemotherapy or other therapy experimental or proven that is or may be active against myeloma within two weeks (14 days) prior to Cycle 1 Day 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6 - 24 months | Progression-free survival will be defined as the time between randomization and the date of progression that occurred during the Core Phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to 24 months | OS is defined as time from randomization to death from any cause during the Core Phase of the study. |
| Overall response rate (ORR) | 6 - 24 months | 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. |
| Adverse Events | Up to 24 months | 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. |
Countries
Canada, Czechia, Ireland, Israel, Russia, Slovakia, South Korea, Spain, United States
Outcome results
None listed