Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients

Multiple Myeloma Clinical Trial

Official title:

A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib and Dexamethasone in Multiple Myeloma Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01002248
• Other study ID #: Perifosine 339
• Status: Terminated
• Phase: Phase 3
• First received: October 23, 2009
• Last updated: February 6, 2018
• Start date: December 2009
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: AEterna Zentaris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A pre-planned interim analysis is expected to take place in Q1 of 2013.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 135
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Perifosine
Perifosine will be dosed as one 50 mg pill every day of each cycle.
• Perifosine Placebo
Perifosine placebo will be dosed as one 50 mg pill every day of each cycle.
• Bortezomib
Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
• Dexamethasone
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.

Locations

Country	Name	City	State
Ireland	Keryx / AOI Pharmaceuticals Investigative Site	Dublin 7
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
AEterna Zentaris	Dana-Farber Cancer Institute

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Ireland,  Israel,  Korea, Republic of,  Russian Federation,  Slovakia,  Spain, 

References & Publications (1)

Richardson PG, Nagler A, Ben-Yehuda D, Badros A, Hari P, Hajek R, Spicka I, Kaya H, Le Blanc R, Yoon SS, Kim K, Martinez-Lopez J, Mittelman M, Shpilberg O, Tothova E, Laubach JP, Ghobria IM, Leiba M, Gatt ME, Sportelli P, Chen M, Anderson KC. Randomized P

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 - 24 months
Secondary	Overall survival (OS)	OS is defined as time from randomization to death from any cause during the Core Phase of the study.	Up to 24 months
Secondary	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.	6 - 24 months
Secondary	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.	Up to 24 months