Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma
Overview[ - collapse ][ - ]
| Purpose | This is an open label phase I/II trial to determine the safety and the biologic activity of the bendamustine, bortezomib and pegylated liposomal doxorubicin combination. |
|---|---|
| Condition | Multiple Myeloma |
| Intervention | Drug: Bendamustine Drug: Doxorubicin Drug: Bortezomib Drug: Bendamustine Drug: Filgrastim |
| Phase | Phase 1/Phase 2 |
| Sponsor | Hoosier Oncology Group |
| Responsible Party | Hoosier Oncology Group |
| ClinicalTrials.gov Identifier | NCT01177683 |
| First Received | August 5, 2010 |
| Last Updated | February 12, 2014 |
| Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 5, 2010 |
|---|---|
| Last Updated Date | February 12, 2014 |
| Start Date | July 2010 |
| Estimated Primary Completion Date | December 2015 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma |
|---|---|
| Official Title | A Phase I/II Trial of Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed or Refractory Multiple Myeloma |
| Brief Summary | This is an open label phase I/II trial to determine the safety and the biologic activity of the bendamustine, bortezomib and pegylated liposomal doxorubicin combination. |
| Detailed Description | Phase I component Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 Doxorubicin 30 mg/m2 IV over 1 hour, Day 4 Bendamustine escalating cohorts IV over 1 hour, Days 1 and 4 1 Cycle = 28 days Phase II component Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 Doxorubicin 30 mg/m2 IV over 1 hour, Day 4 Bendamustine at MTD IV over 1 hour, Days 1 and 4 Filgrastim (if defined in MTD) 5 µg/kg/day SC, Starting day 6 until neutrophil recovery to ANC >1000 1 Cycle = 28 days; Patients will continue treatment for a total of up to 8 cycles. ECOG Performance Status: 0-2 Hematopoietic: - Absolute neutrophil count (ANC) ≥ 1.2 x K/mm3 - Platelets ≥ 75 x K/mm3 Hepatic: - Total bilirubin ≤ 1.5 x upper limit of normal (ULN) - AST ≤ 2.5 x ULN - ALT ≤ 2.5 x ULN Renal: - Serum creatinine < 3.0 mg/dL Cardiovascular: - LVEF >45% corrected by MUGA scan or echocardiogram. - No unstable angina pectoris or recent myocardial infarction (within 6 months) |
| Study Type | Interventional |
| Study Phase | Phase 1/Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Multiple Myeloma |
| Intervention | Drug: Bendamustine Phase I component: Bendamustine escalating cohorts to determine MTD, IV over 1 hour, Days 1 and 4 Drug: Doxorubicin Phase I and II components: Pegylated liposomal doxorubicin, 30 mg/m2 IV over 1 hour, Day 4 Drug: Bortezomib Phase I and II components: Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 Drug: Bendamustine Phase II component: Bendamustine at at MTD IV over 1 hour, Days 1 and 4 Drug: Filgrastim Phase II component: Filgrastim (if defined in MTD) 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC >1000 |
| Study Arm (s) | Experimental: Arm 1 Bendamustine in combination with bortezomib and pegylated liposomal doxorubicin. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 69 |
| Estimated Completion Date | December 2015 |
| Estimated Primary Completion Date | December 2015 |
| Eligibility Criteria | Inclusion Criteria: - A histologically established diagnosis of multiple myeloma with evidence of relapse or refractory disease. - Must have a detectable serum or urine M-Protein by protein electrophoresis that is at least 500 mg/dL (serum) or 1 gm/24 hours (urine), respectively, or serum free light chain level >100 mg/l for the involved free light chain. - Must have received at least one (1) prior line of systemic treatment that has included either lenalidomide or thalidomide. - Must be willing to provide correlative blood samples. Exclusion Criteria: - Must not have received an excessive cumulative dose of anthracycline - No ≥ grade 2 peripheral neuropathy. - No cytotoxic chemotherapy within 30 days prior to registration for protocol therapy. - No autologous stem cell transplant within 6 months prior to registration for protocol therapy - No prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis) within 30 days prior to registration for protocol therapy. See Study Procedures Manual to calculate percent of prior radiation. - No current corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions. - No known central nervous system involvement by myeloma. - No poorly controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social climate that in the opinion of the investigator would limit compliance with study requirements. - No patients known to be positive for HIV, or active Hepatitis A, B, or C. - No major surgery within 30 days prior to registration for protocol therapy. Placement of a venous access device within 30 days prior to registration for protocol therapy is allowed. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Sherif Farag, M.B., B.S. ssfarag@iupui.edu |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01177683 |
|---|---|
| Other Study ID Numbers | MM08-141 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Hoosier Oncology Group |
| Study Sponsor | Hoosier Oncology Group |
| Collaborators | Cephalon |
| Investigators | Study Chair: Sherif Farag, M.B., B.S. Hoosier Oncology Group |
| Verification Date | February 2014 |
Locations[ + expand ][ + ]
| Cancer Care Center of Southern Indiana | Bloomington, Indiana, United States, 47403 Withdrawn |
|---|---|
| IU Health Goshen Hospital | Goshen, Indiana, United States, 46527 Contact: Alex Starodub, M.D. | 574-535-2886 | astarodub@iuhealth.orgRecruiting |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana, United States, 46202 Contact: Sherif Farag, M.B., B.S. | 317-274-0843 | ssfarag@iupui.eduRecruiting |
| Community Regional Cancer Center | Indianapolis, Indiana, United States, 46256 Contact: Anuj Agarwala, M.D. | 317-621-7104Recruiting |
| IU Health Central Indiana Cancer Centers | Indianapolis, Indiana, United States, 46219 Contact: Hillary Wu, M.D. | 317-964-5253 | hwu@iuhealth.orgRecruiting |
| IU Health Arnett Cancer Center | Lafayette, Indiana, United States, 47904 Contact: Thomas Jones, M.D. | 765-448-7500Recruiting |
| Floyd Memorial Cancer Center of Indiana | New Albany, Indiana, United States, 47150 Withdrawn |
| Metro Health Cancer Care | Wyoming, Michigan, United States, 49519 Terminated |
| University Hospitals Seidman Cancer Center | Cleveland, Ohio, United States, 44106 Contact: Erica Campagnaro, D.O. | 216-844-5884 | erica.campagnaro@uhhospitals.orgRecruiting |