A Study of Pegylated Liposomal Doxorubicin (PLD), Bortezomib, Dexamethasone and Lenalidomide for Patients With Relapsed/Refractory Multiple Myeloma (DVD-R)
This is a phase II, multicenter, open label, nonrandomized study to evaluate the efficacy and safety of lenalidomide at a dose of 10 mg/dose in combination with bortezomib at 1.0 mg/m2/dose, pegylated liposomal doxorubicin (PLD) at 4.0 mg/m2/dose, and intravenous (IV) dexamethasone at 40 mg/dose in adult patients with relapsed/refractory multiple myeloma. The study consists of a screening period, followed by up to eight 28 day open label treatment cycles, a final assessment to occur 28 days after the end of the last treatment cycle, and a follow-up period.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide (DVD-R) for Patients With Relapsed/Refractory Multiple Myeloma|
- IMWG Response Criteria [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]The investigator will evaluate each patient for response to therapy according to criteria augmented from those developed by Bladé et al., 1998 presented below (Table 7-1). Assessment of disease response will be performed prior to drug administration on Day 1 of Cycles 2 8 and at the End of Study Treatment visit. If a patient is determined to have CR, VGPR, PR, or MR, then assessment of disease response is to be performed 4 weeks later to confirm the response.
- Adverse Events [ Time Frame: up to 36 weeks ] [ Designated as safety issue: Yes ]Occurrence of adverse events throughout the study using CTCAE ctriteria version 3.0.
- Clinical laboratory [ Time Frame: up to 32 weeks ] [ Designated as safety issue: Yes ]
- Hematology (hematocrit, hemoglobin, RBC count, WBC count, with differential, platelet count.
- Serum electrolyte and glucose panel (sodium, potassium, chloride, calcium, and glucose).
- Serum beta human chorionic gonadotropin pregnancy test for women of child-bearing potential
- Chemistry [BUN, serum creatinine, bilirubin (total), alkaline phosphatase, total protein, albumin, AST (SGOT), ALT (SGPT)]
- Vital signs [ Time Frame: up to 32 weeks ] [ Designated as safety issue: Yes ]Pulse, blood pressure, respiratory rate, and body temperature
- Medical history [ Time Frame: up to 32 weeks ] [ Designated as safety issue: Yes ]
- Physical Examination [ Time Frame: up to 32 weeks ] [ Designated as safety issue: Yes ]Body weight measurements
- Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: up to 32 weeks ] [ Designated as safety issue: Yes ]
SCORE DESCRIPTION 0 Fully active, able to carry on all pre-disease performance without restriction.
- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- Concomitant medication usage [ Time Frame: up to 32 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2009|
|Study Completion Date:||February 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: DVD-R single arm
Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin + Lenalidomide (DVD-R) Therapy:
Dexamethasone*- 40 mg IV Bortezomib**- 1.0 mg/m2 IV Push Pegylated Liposomal Doxorubicin*- 4.0 mg/m2 IV Lenalidomide***- 10 mg PO
Per 28 Day Cycle
IV dexamethasone at 40 mg will be administered on Days 1, 4, 8, and 11 of each cycle. Bortezomib will be administered at 1.0 mg/m2/dose as an IV push over 3 to 5 seconds followed by a standard saline flush. Doses are administered on Days 1, 4, 8, and 11. Bortezomib will be administered immediately following the dexamethasone infusion. PLD will be given at a dose of 4.0 mg/m2 as a 90 minute IV infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle. Doses will be administered following the bortezomib administration. Lenalidomide will be administered at a dose of 10 mg PO. Doses are to be administered once-a-day, for the first 14 days, as part of a 28-day treatment cycle, followed by a 14-day rest period. Doses will be administered following the PLD administration.
|United States, California|
|Comprehensive Blood and Cancer Center|
|Bakersfield, California, United States, 93309|
|Hematology-Oncology Medical Group of Fresno, Inc.|
|Fresno, California, United States, 93720|
|Loma Linda University|
|Loma Linda, California, United States, 92354|
|Santa Barbara Hematology Oncology|
|Santa Barbara, California, United States, 93105|
|James R. Berenson, M.D., Inc.|
|West Hollywood, California, United States, 90069|
|United States, Florida|
|Watson Clinic, LLP, Center for Care and Research|
|Lakeland, Florida, United States, 33805|
|United States, New York|
|Bassett Cancer Institute|
|Cooperstown, New York, United States, 13326|
|Johnson City, New York, United States, 13790|
|Principal Investigator:||James R. Berenson, MD||James R. Berenson, MD, Inc.|