Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant



Status:Archived
Conditions:Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:October 2010

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A Phase II Study of Bortezomib, Liposomal Doxorubicin, Dexamethasone, and Cyclophosphamide in Patients With Multiple Myeloma Relapsing Within 12 Months of Autologous Stem Cell Transplant


RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as liposomal doxorubicin
hydrochloride, dexamethasone, and cyclophosphamide, work in different ways to stop the
growth of cancer cells, either by killing the cells or by stopping them from dividing.
Giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and
cyclophosphamide may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with liposomal
doxorubicin hydrochloride, dexamethasone, and cyclophosphamide works in treating patients
with multiple myeloma that relapsed after autologous stem cell transplant.


OBJECTIVES:

Primary

- To evaluate the 1-year survival of patients with relapsed multiple myeloma treated with
bortezomib, pegylated liposomal doxorubicin hydrochloride, dexamethasone, and
cyclophosphamide.

Secondary

- To evaluate response rates in patients treated with this regimen.

- To evaluate the median time to progression in patients treated with this regimen.

- To evaluate the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV on days 1, 4, 8, and 11; pegylated liposomal doxorubicin
hydrochloride IV over 1 hour on day 4; oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and
12; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to
12 courses in the absence of disease progression or unacceptable toxicity.

Peripheral blood and bone marrow samples may be collected for future research.

Patients complete the FACT neurotoxicity questionnaire periodically.

After completion of study treatment, patients are followed up every 3 months for 3 years.


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