Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients
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ClinicalTrials.gov Identifier: NCT01002248 |
Recruitment Status :
Terminated
First Posted : October 27, 2009
Last Update Posted : February 9, 2018
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Condition or disease | Intervention/treatment | Phase |
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Multiple Myeloma | Drug: Perifosine Drug: Perifosine Placebo Drug: Bortezomib Drug: Dexamethasone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 135 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | December 2009 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |

Arm | Intervention/treatment |
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Experimental: Perifosine added to combination
Perifosine added to the combination of Bortezomib and Dexamethasone. Perifosine is is supplied as a film-coated tablet containing 50 mg of active ingredient. Perifosine will be administered orally on an outpatient basis throughout the study. Daily administration will be one 50 mg tablet. The first dose of perifosine should be taken on the same day that bortezomib and dexamethasone are administered (Cycle 1 Day 1). |
Drug: Perifosine
Perifosine will be dosed as one 50 mg pill every day of each cycle.
Other Names:
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: Perifosine Placebo added to combination
Perifosine placebo added to the combination of Bortezomib and Dexamethasone. The placebo for perifosine is provided in 256 mg white to off-white, round, biconvex film-coated tablets to permit a blinded trial with perifosine 50 mg film coated tablets. Placebo will be administered orally on an outpatient basis throughout the study. Daily administration will be one perifosine placebo tablet. The first dose of placebo should be taken on the same day that bortezomib and dexamethasone are administered (Cycle 1 Day 1).
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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. |
- 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 ]Progression-free survival will be defined as the time between randomization and the date of progression that occurred during the Core Phase.
- Overall survival (OS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002248

Principal Investigator: | Paul Richardson, MD | Dana-Farber Cancer Institute |
Responsible Party: | AEterna Zentaris |
ClinicalTrials.gov Identifier: | NCT01002248 |
Other Study ID Numbers: |
Perifosine 339 |
First Posted: | October 27, 2009 Key Record Dates |
Last Update Posted: | February 9, 2018 |
Last Verified: | March 2013 |
Multiple Myeloma Relapsed multiple myeloma Refractory multiple myeloma Relapsed refractory multiple myeloma |
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 Bortezomib 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 |