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Sponsored by: |
University of California, San Francisco |
Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00516191 |
The primary objective of this study is to evaluate the safety and tolerability of four dose levels of liposomal doxorubicin, melphalan, and bortezomib in patients with relapsed/refractory MM and to identify a maximum tolerated dose (MTD) of this combination.
Condition | Intervention | Phase |
Multiple Myeloma |
Drug: Liposomal Doxorubicin/Melphalan/Bortezomib |
Phase I Phase II |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Multiple Myeloma |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Melphalan Bortezomib Melphalan hydrochloride Sarcolysin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Liposomal Doxorubicin (Doxil)/Melphalan/Bortezomib (Velcade) in Relapsed/Refractory Multiple Myeloma |
Estimated Enrollment: | 30 |
Study Start Date: | October 2004 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Day 1 Bortezomib 0.7 mg/m(2)IV + Doxil 10-20 mg/m(2)IV+Melphalan 5-10mg/m(2)IV Day 4 Bortezomib 0.7 mg/m(2)IV Day 8 Bortezomib 0.7 mg/m(2)IV Day 11 Bortezomib 0.7 mg/m(2)IV
The treatment cycles will be repeated every 28 days. Dose Level 1: Doxil 10mg/m(2), Melphalan 5 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 2: Doxil 10mg/m(2), Melphalan 10 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 3: Doxil 20mg/m(2), Melphalan 10 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 4: Doxil 20mg/m(2), Melphalan 10 mg/m(2), Bortezomib 1.0mg/m(2)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Initial Required Laboratory Values within 14 days of baseline i.e. Cycle 1, Day 1 (note that renal insufficiency, including dialysis dependence is permissable):
Prior therapy: Patient must have had at least 2 prior therapeutic regimens as defined below for treatment of multiple myeloma
Prior nonmyeloablative transplantation allowed provided patient does not have significant graft-versus-host disease and is off aggressive immunosuppressive therapy for at least 30 days. Low dose immunosuppression is allowed (i.e. Prednisone at dose < or equal to 10 mg daily, low dose tacrolimus (subtherapeutic levels) or other agents with equivalent low-dose immunosuppression).
Exclusion Criteria:
Contact: Beth Davis, C.C.R.A. | 415-502-3176 | bdavis@medicine.ucsf.edu |
Contact: Natalie J. Jeha, M.A. | 415-476-4126 | njeha@medicine.ucsf.edu |
United States, California | |||||
University of California San Francisco | Recruiting | ||||
San Francisco, California, United States, 94143 | |||||
Contact: Beth Davis, C.C.R.A. 415-502-3176 bdavis@medicine.ucsf.edu | |||||
Contact: Natalie Jeha, M.A. 415-476-4126 njeha@medicine.ucsf.edu | |||||
Sub-Investigator: Jeffrey Wolf, M.D. | |||||
Sub-Investigator: Wei Ai, M.D. | |||||
Sub-Investigator: Charles A. Linker, M.D. | |||||
Sub-Investigator: Lloyd Damon, M.D. | |||||
Sub-Investigator: Karin Gaensler, M.D. | |||||
Sub-Investigator: Lawrence D. Kaplan, M.D. | |||||
Sub-Investigator: Peter Sayre, M.D. | |||||
United States, New York | |||||
Herbert Irving Comprehensive Cancer Center Division of Hematology/Oncology, Columbia University Medical Center | Recruiting | ||||
New York City, New York, United States, 10032 | |||||
Contact: Sean Clark-Garvey, M.P.H. 212-305-0435 sc2359@columbia.edu | |||||
Principal Investigator: Ajai Chari, M.D. |
University of California, San Francisco |
Principal Investigator: | Thomas G. Martin, M.D. | University of California, San Francisco |
UCSF Cancer Center Home Page 
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Responsible Party: | University of California San Francisco ( Thomas Martin, MD, Assistant Clinical Professor Medicine ) |
Study ID Numbers: | UC-2408 |
First Received: | August 13, 2007 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00516191 |
Health Authority: | United States: Institutional Review Board |
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