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

Sponsor:	Keryx / AOI Pharmaceuticals, Inc.
Collaborator:	Dana-Farber Cancer Institute
Information provided by (Responsible Party):	Keryx / AOI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01002248

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 III

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: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Perifosine Bortezomib Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Keryx / AOI Pharmaceuticals, Inc.:

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 ]

Estimated Enrollment:	450
Study Start Date:	December 2009
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	September 2012 (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.

Eligibility

Ages Eligible for Study:	18 Years and older
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

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

Contacts

Contact: Keryx / AOI Pharmaceuticals

212-531-5964

Show 78 Study Locations

Sponsors and Collaborators

Keryx / AOI Pharmaceuticals, Inc.

Dana-Farber Cancer Institute

Investigators

Principal Investigator:

Paul Richardson, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Keryx / AOI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01002248 History of Changes
Other Study ID Numbers:	Perifosine 339
Study First Received:	October 23, 2009
Last Updated:	February 7, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Keryx / AOI Pharmaceuticals, Inc.:

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
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on February 09, 2012