Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Perifosine Drug: Perifosine Placebo Drug: Bortezomib Drug: Dexamethasone	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple myeloma

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate Bortezomib

Genetic and Rare Diseases Information Center resources: Multiple Myeloma

U.S. FDA Resources

Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:

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 [ Time Frame: 6 - 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Overall response rate [ Time Frame: 6 - 24 months ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]


Enrollment:	135
Study Start Date:	December 2009
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Perifosine + Bortezomib + Dexamethasone	Drug: Perifosine Perifosine will be dosed as one 50 mg pill every day of each cycle. Drug: Bortezomib Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days. Drug: 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.
Placebo Comparator: Placebo + Bortezomib + Dexamethasone	Drug: Perifosine Placebo Perifosine placebo will be dosed as one 50 mg pill every day of each cycle. Drug: Bortezomib Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days. Drug: 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.

Detailed Description:

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002248

Show 88 Study Locations

Sponsors and Collaborators

AEterna Zentaris

Dana-Farber Cancer Institute

Investigators


Principal Investigator:	Paul Richardson, MD	Dana-Farber Cancer Institute

More Information

Publications:

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 Placebo-Controlled Phase III Study Of Perifosine Combined With Bortezomib and Dexamethasone In Relapsed, Refractory Multiple Myeloma Patients Previously Treated With Bortezomib. Blood 2013 ASH Meeting Proceedings;122:abstract 3189


Responsible Party:	AEterna Zentaris
ClinicalTrials.gov Identifier:	NCT01002248 History of Changes
Other Study ID Numbers:	Perifosine 339
Study First Received:	October 23, 2009
Last Updated:	February 14, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by AEterna Zentaris:


Multiple Myeloma Relapsed multiple myeloma Refractory multiple myeloma Relapsed refractory multiple myeloma

Additional relevant MeSH terms:


Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate	Dexamethasone Dexamethasone 21-phosphate Bortezomib BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents

ClinicalTrials.gov processed this record on September 30, 2016