NCT00849251

Pegylated Liposomal Doxorubicin Hydrochloride, Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Multiple Myeloma

Combination Pegylated Liposomal Doxorubicin, Bortezomib, Cyclophosphamide, and Dexamethasone for Multiple Myeloma (PLD-BCD)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving pegylated liposomal doxorubicin hydrochloride together with bortezomib, cyclophosphamide, and dexamethasone may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects of giving pegylated liposomal doxorubicin hydrochloride together with bortezomib, cyclophosphamide, and dexamethasone and to see how well it works in treating patients with multiple myeloma

Detailed description

PRIMARY OBJECTIVES: I. To determine efficacy of this novel combination in newly diagnosed patients with multiple myeloma. SECONDARY OBJECTIVES: I. To determine the toxicity of this novel combination regimen in previously treated patients and newly diagnosed patients with multiple myeloma. OUTLINE: Patients receive cyclophosphamide intravenously (IV) or orally (PO) over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of treatment, patients are followed up every 3 months for 2 years, then annually up to 5 years.

Conditions

• Refractory Multiple Myeloma
• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

Interventions

Type	Name	Description
DRUG	cyclophosphamide	Given IV or PO
DRUG	pegylated liposomal doxorubicin hydrochloride	Given IV
DRUG	bortezomib	Given IV
DRUG	dexamethasone	Given IV or PO

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-12-01
• Completion: 2015-06-01
• First posted: 2009-02-23
• Last updated: 2017-09-08
• Results posted: 2017-09-08

Locations

1 site across 1 country: United States