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| Sponsors and Collaborators: |
Sheba Medical Center Fo.Ne.Sa.Group of Oncology, Italy |
|---|---|
| Information provided by: | Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT00551928 |
Purpose
A phase 3 randomized study that compares high dose Melphalan with the combination of Lenalidomide, Melphalan and steroids as consolidation therapy for newly diagnosed young multiple Myeloma patients that were treated with Lenalidomide and Dexamethasone for first line therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma Newly Diagnosed Patients |
Drug: Melphalan Drug: Lenalidomide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
| Official Title: | Lenalidomide Melphalan and Prednisone Versus High Dose Melphalan in Newly Diagnosed Multiple Myeloma Patients |
| Estimated Enrollment: | 386 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
Oral therapy with Lenalidomide Melphalan and steroids.
|
Drug: Lenalidomide
Six months of oral therapy with Lenalidomide 10mg/day given 21 days in every 28 days cycle with the combination ofMelphalan and steroids.
|
|
B: Active Comparator
High dose Melphalan therapy (200mg/sm)with autologous stem cell support.
|
Drug: Melphalan
High dose Melphalan 200mg/sm with autologous stem cell support
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Izhar hardan, MD | +97235302174 ext 2174 | izhar.hardan@sheba.health.gov.il |
| Israel | |
| Hematology department, Sheba Medical center | Recruiting |
| Tel Hashomer, Israel, 52621 | |
| Contact: Izhar Hardan, MD +972 3 5302174 ext 2174 izhar.hardan@sheba.health.gov.il | |
| Contact: Arnon nagler, MD +9725305850 ext 5850 arnon.nagler@sheba.health.gov.il | |
| Principal Investigator: Izhar Hardan, MD | |
| Principal Investigator: | Izhar Hardan, MD | Sheba Medical Center, Tel-Hashomer Israel |
More Information
| Responsible Party: | Israeli Myeloma study group ( Izhar Hardan MD secretary ) |
| Study ID Numbers: | SHEBA-07-4918-IH-CTIL |
| Study First Received: | October 30, 2007 |
| Last Updated: | January 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00551928 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
Multiple Myeloma Lenalidomide High dose Melphalan |
|
Melphalan Prednisone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Lenalidomide Vascular Diseases |
Paraproteinemias Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Alkylating Agents |
