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

Stopped early · Phase 2

Conditions studied: Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT01078441

Run by

National Cancer Institute (NCI)

People needed

2

Starts

2010-09-01

Expected to finish

2014-03-01

Last updated by the study team

2015-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Medical Center of Aurora — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Exempla Saint Joseph Hospital — Denver, Colorado, United States
• Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Colorado Cancer Research Program CCOP — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Saint Anthony Hospital — Lakewood, Colorado, United States
• Littleton Adventist Hospital — Littleton, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Longmont United Hospital — Longmont, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• Parker Adventist Hospital — Parker, Colorado, United States
• Saint Mary Corwin Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Medical Center of Central Georgia — Macon, Georgia, United States
• Saint Joseph Medical Center — Bloomington, Illinois, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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