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| ID | Type | Description | Link |
|---|---|---|---|
| RV-MM-PI-142 |
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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Brigham and Women's Hospital | OTHER |
| Mayo Clinic | OTHER |
| Memorial Sloan Kettering Cancer Center |
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The purpose of this research study is to determine the highest dose of lenalidomide and RAD001 that can be given without causing too many serious side effects. Another goal of this research study is to look at how the participants cancer may respond to the study treatment. Additionally, we wish to learn more about how the body breaks down and gets rid of the study drugs. We will also try to find substances in the blood (biomarkers) that may help predict how myeloma will respond to study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Single arm phase I study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001 | Drug | Dose levels will change: Taken orally either every other day for the first three weeks of each cycle or taken every day for the first three weeks of each cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of RAD001 when given in combination with lenalidomide and to identify the maximum tolerated dose (MTD) as well as a recommended Phase 2 dose for the combination in this patient population. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the response to the combination of RAD001 and lenalidomide in subjects with multiple myeloma. | 2 years | |
| To determine the pharmacokinetics of RAD001 and lenalidomide. | 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noopur Raje, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24761838 | Result | Yee AJ, Hari P, Marcheselli R, Mahindra AK, Cirstea DD, Scullen TA, Burke JN, Rodig SJ, Hideshima T, Laubach JP, Ghobrial IM, Schlossman RL, Munshi NC, Anderson KC, Weller EA, Richardson PG, Raje NS. Outcomes in patients with relapsed or refractory multiple myeloma in a phase I study of everolimus in combination with lenalidomide. Br J Haematol. 2014 Aug;166(3):401-9. doi: 10.1111/bjh.12909. Epub 2014 Apr 25. |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D010797 |
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| OTHER |
| Medical College of Wisconsin | OTHER |
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| lenalidomide | Drug | Dose level will vary: taken orally 30-60 minutes after taking RAD001 every day for the first three weeks of each cycle. |
|
| To identify possible surrogate markers to better define mechanisms of action for the combination of the two drugs. |
| 2 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226' | United States |
| 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 |
| Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |