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

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: BB 1101; Bortezomib; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Diagnosis of multiple myeloma that was symptomatic at the time of initial diagnosis

• Must have met the following criteria at one point during the disease course:

• Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytoma

• Symptomatic disease at initial diagnosis that prompted the initiation of therapy as well as evidence of end-organ damage at the time of diagnosis, including at least 1 of the following:

• Anemia

• Hypercalcemia

• Bone disease (lytic bone lesions or pathologic fracture)

• Renal dysfunction

• Disease relapsed < 12 months after autologous stem cell transplantation (SCT)

• Measurable disease, as defined by the presence of ≥ 1 of the following:

• Serum M-spike ≥ 1 g/dL

• Urine M-spike ≥ 200 mg/24 hours

• Involved free light chain (FLC) ≥ 10 mg/dL (provided the serum FLC is abnormal)

• Plasma cells ≥ 30%

• ECOG performance status 0-2

• Negative pregnancy test

• Fertile patients must use effective contraception

• At least 14 days since prior palliative and/or localized radiotherapy

• Left ventricular ejection fraction (LVEF) normal by Echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan

• Hemoglobin > 8 g/dL

• Platelet count ≥ 75,000/mm^3 (without transfusion support)

• Absolute neutrophil count (ANC) ≥ 1,000/mm^3 (without use of growth factors)

• Creatinine < 2.5 mg/dL

• Direct bilirubin ≤ 1.5 mg/dL

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal

• All tests below must be performed within 14 days prior to registration:

• Serum free light chain assay

• Kappa free light chain

• Lambda free light chain

• Prior malignancy allowed provided it was treated curatively and has not relapsed in 5 years

• Patients with basal cell skin cancer, in situ cervical cancer, or prostate cancer not requiring therapy are eligible

Exclusion Criteria:

• Therapy for relapsed disease following SCT

• Known allergy to bortezomib or anthracyclines

• Prior allogeneic SCT

• Peripheral neuropathy ≥ grade 2 according to the Cancer Therapy Evaluation Program (CTEP) active version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)

• Concurrent uncontrolled illness that would limit study compliance, including the following:

• Uncontrolled hypertension

• Symptomatic congestive heart failure

• Unstable angina

• Uncontrolled cardiac arrhythmia

• Uncontrolled psychiatric illness or social situation

• Active uncontrolled infection

• Prior doxorubicin hydrochloride exposure > 240 mg/m^2

• Active, uncontrolled seizure disorder

• Seizures within the past 6 months

• Pregnant or nursing