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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
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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.
A pre-planned interim analysis is expected to take place in Q1 of 2013.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perifosine added to combination | Experimental | 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). |
|
| Perifosine Placebo added to combination | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perifosine | Drug | Perifosine will be dosed as one 50 mg pill every day of each cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Richardson, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Verne | California | 91750 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
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| Perifosine Placebo | Drug | Perifosine placebo will be dosed as one 50 mg pill every day of each cycle. |
|
| Bortezomib | Drug | Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days. |
|
| Dexamethasone | Drug | Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle. |
|
| 6 - 24 months |
| 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 |
| San Francisco |
| California |
| 94143 |
| United States |
| San Pablo | California | 94806 | United States |
| Aurora | Colorado | 80012 | United States |
| Boulder | Colorado | 80303 | United States |
| Colorado Springs | Colorado | 80909 | United States |
| Denver | Colorado | 80218 | United States |
| Lakewood | Colorado | 80228 | United States |
| Littleton | Colorado | 80120 | United States |
| Longmont | Colorado | 80501 | United States |
| Parker | Colorado | 80138 | United States |
| Pueblo | Colorado | 81008 | United States |
| Thornton | Colorado | 80260 | United States |
| Niles | Illinois | 60714 | United States |
| Winfield | Illinois | 60190 | United States |
| Baltimore | Maryland | 21201 | United States |
| Columbia | Maryland | 21044 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Morristown | New Jersey | 07960 | United States |
| Great Neck | New York | 11042 | United States |
| Fargo | North Dakota | 58122 | United States |
| Portland | Oregon | 97225 | United States |
| Tualatin | Oregon | 97062 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Bedford | Texas | 76022 | United States |
| Dallas | Texas | 75246 | United States |
| Fort Worth | Texas | 76104 | United States |
| Kerrville | Texas | 78028 | United States |
| San Antonio | Texas | 78217 | United States |
| San Antonio | Texas | 78229 | United States |
| Tyler | Texas | 75702 | United States |
| Ogden | Utah | 84403 | United States |
| Christiansburg | Virginia | 24073 | United States |
| Roanoke | Virginia | 24014 | United States |
| Salem | Virginia | 24153 | United States |
| Seattle | Washington | 98133 | United States |
| Spokane | Washington | 99202 | United States |
| Vancouver | Washington | 98686 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Winnipeg | Manitoba | R3E 0V9 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Québec | Quebec | G1R 2J6 | Canada |
| Brno | Czech Republic | 62500 | Czechia |
| Prague | Czech Republic | 12821 | Czechia |
| Keryx / AOI Pharmaceuticals Investigative Site | Dublin | Ireland |
| Dublin | Ireland |
| Galway | Ireland |
| Limerick | Ireland |
| Sligo | Ireland |
| Tullamore | Ireland |
| Waterford | Ireland |
| Afula | 18101 | Israel |
| Ashkelon | 78278 | Israel |
| Beersheba | 84101 | Israel |
| Haifa | 31096 | Israel |
| Jerusalem | 91031 | Israel |
| Jerusalem | 91120 | Israel |
| Nahariya | 22100 | Israel |
| Petah Tikva | 49100 | Israel |
| Rehovot | 76100 | Israel |
| Tel Aviv | 64239 | Israel |
| Tel Litwinsky | 52621 | Israel |
| Moscow | 125284 | Russia |
| Moscow | 129110 | Russia |
| Saint Petersburg | 191024 | Russia |
| Saint Petersburg | 197022 | Russia |
| Samara | 443095 | Russia |
| Košice | Slovak Republic | 04166 | Slovakia |
| Seoul | 110-744 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 137-701 | South Korea |
| Seoul | 138-736 | South Korea |
| Badalona | 08916 | Spain |
| Barcelona | 08025 | Spain |
| Barcelona | 08035 | Spain |
| Barcelona | 08036 | Spain |
| Madrid | 28006 | Spain |
| Madrid | 28034 | Spain |
| Madrid | 28040 | Spain |
| Madrid | 28041 | Spain |
| Pamplona | 31008 | Spain |
| San Cristóbal de La Laguna | 38320 | Spain |
| Valencia | 46026 | Spain |
| Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C105905 | perifosine |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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