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Sponsors and Collaborators: |
Massachusetts General Hospital Celgene Corporation Dana-Farber Cancer Institute |
Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00580242 |
This study proposes using bortezomib in cohorts of 3-6 patients at the doses of 0.7, 1, and 1.3 mg/m2 on days 1, 4, 8, and 11 to determine the MTD in combination with lenalidomide 10 mg a day, for 21 days of a 28 day treatment cycle for patients with myelodysplastic syndrome.
Condition | Intervention | Phase |
Myelodysplasia |
Drug: Bortezomib Drug: Lenalidomide |
Phase I |
ChemIDplus related topics: | Bortezomib Lenalidomide CC 5013 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Dose Escalating Study of Bortezomib and Lenalidomide in Patients With Untreated or Previously Treated, Primary and Secondary Non 5q- Del Myelodysplasia |
Estimated Enrollment: | 28 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
This is a Phase I dose escalation trial with three cohorts of 3-6 patients each plus 10 additional patients (up to a maximum total of 28 patients) treated at the candidate maximum tolerated dose.Cohorts will receive increasing doses of bortezomib at 0.7, 1, and 1.3 mg/m2 on days 1, 4, 8, and 11 in combination with lenalidomide at 10 mg a day for Days 1-21. Each cycle will be 28 days. Patients will receive up to 9 cycles of treatment, with efficacy assessed after 3, 6, and 9 cycles.
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Drug: Bortezomib
First cohort: Bortezomib 0.7mg/m2 IV on Days on Days 1, 4, 8, and 11. Patients may receive up to 9 cycles with each cycle lasting a total of 28 days
Drug: Bortezomib
Second cohort: Bortezomib 1mg/m2 IV on Days 1, 4, 8, and 11 Patients may receive up to 9 cycles with each cycle lasting a total of 28 days
Drug: Bortezomib
Third Cohort: Bortezomib 1.3mg/m2 IV on Days 1, 4, 8, and 11 of each cycle Patients may receive up to 9 cycles with each cycle lasting a total of 28 days
Drug: Lenalidomide
Lenalidomide 10 mg PO QD on Days 1 -21 followed by a 7 day rest period
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Currently, there are no curative therapies for myelodysplasia except for allogeneic stem cell transplantation. Both lenalidomide and bortezomib have activity as single agents in patients with myelodysplasia. This study proposes using bortezomib in cohorts of 3-6 patients at the doses of 0.7, 1, and 1.3 mg/m2 on days 1, 4, 8, and 11 to determine the MTD in combination withlenalidomide 10 mg a day, for 21 days of a 28 day treatment cycle. The planned bortezomib doses have been evaluated in previous Phase I clinical studies in similar patient populations and have been safe and well tolerated in a twice-weekly schedule of administration. Lenalidomide has been shown to have efficacy in myelodysplasia. The combination of lenalidomide and bortezomib has been used in patients with multiple myeloma.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Karen Ballen, MD | 617 726 6533 | kballen@partner.org |
Contact: Christine Connolly | 617 726 5131 | cconnolly1@partners.org |
United States, Massachusetts | |||||
Massachusetts General Hospital | Recruiting | ||||
Boston, Massachusetts, United States, 02114 | |||||
Contact: Karen Ballen, M.D. 617-724-1124 kballen@partners.org | |||||
Contact: Christine Connolly 617 726 5131 cconnolly1@partners.org | |||||
Sub-Investigator: Eyal Attar, M.D | |||||
Sub-Investigator: Philip Amrein, M.D. | |||||
Sub-Investigator: Thomas Spitzer, M.D. | |||||
Sub-Investigator: Steven McAfee, M.D. | |||||
Dana Farber Cancer Institute | Recruiting | ||||
Boston, Massachusetts, United States, 02115 | |||||
Contact: Richard Stone, M.D. 617-632-2214 richard.stone@dfci.harvard.edu | |||||
Sub-Investigator: Daniel Angelo, MD | |||||
Sub-Investigator: Andriana Penicaud, PA | |||||
Sub-Investigator: Andres Sirulnik, MD | |||||
Sub-Investigator: Martha Wadleigh, MD |
Massachusetts General Hospital |
Celgene Corporation |
Dana-Farber Cancer Institute |
Principal Investigator: | Karen Ballen, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Karen Ballen, MD ) |
Study ID Numbers: | 07-006, RV-MDS-PI-0161 |
First Received: | December 20, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00580242 |
Health Authority: | United States: Institutional Review Board |
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