Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant
Refractory Multiple Myeloma
About this trial
This is an interventional treatment trial for Refractory Multiple Myeloma focused on measuring Bortezomib, Liposomal Doxorubicin, Dexamethasone, Cyclophosphamide, refractory multiple myeloma
Eligibility 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
Sites / Locations
- Mayo Clinic in Arizona
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Porter Adventist Hospital
- Exempla Saint Joseph Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- Rose Medical Center
- Colorado Cancer Research Program CCOP
- Swedish Medical Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Saint Anthony Hospital
- Littleton Adventist Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Parker Adventist Hospital
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- Medical Center of Central Georgia
- Saint Joseph Medical Center
- Graham Hospital Association
- Memorial Hospital
- Eureka Hospital
- Illinois CancerCare Galesburg
- Mason District Hospital
- Mcdonough District Hospital
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Ottawa Regional Hospital and Healthcare Center
- Pekin Cancer Treatment Center
- Methodist Medical Center of Illinois
- Proctor Hospital
- Illinois CancerCare-Peoria
- Illinois Oncology Research Association CCOP
- OSF Saint Francis Medical Center
- Illinois Valley Hospital
- Perry Memorial Hospital
- Medical Oncology and Hematology Associates-West Des Moines
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Mercy Medical Center - North Iowa
- Siouxland Hematology Oncology Associates
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wichita CCOP
- Cancer Center of Kansas - Winfield
- Union Hospital of Cecil County
- Eastern Cooperative Oncology Group
- Bixby Medical Center
- Hickman Cancer Center
- Community Cancer Center of Monroe
- Mercy Memorial Hospital
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview-Southdale Hospital
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic
- Metro-Minnesota CCOP
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology and Hematology PA-Woodbury
- Cooper Hospital University Medical Center
- Toledo Clinic Cancer Centers-Bowling Green
- The Jewish Hospital
- MetroHealth Medical Center
- North Coast Cancer Care-Clyde
- Community Health Partners Regional Medical Center
- Hematology Oncology Center Incorporated
- Lima Memorial Hospital
- Toledo Clinic Cancer Centers-Maumee
- Fisher-Titus Medical Center
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- North Coast Cancer Care
- Flower Hospital
- Mercy Hospital of Tiffin
- The Toledo Hospital/Toledo Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Fulton County Health Center
- Butler Memorial Hospital
- Geisinger Medical Center
- Geisinger Medical Center-Cancer Center Hazelton
- Geisinger Medical Group
- Geisinger Wyoming Valley
- Fredericksburg Oncology Inc
- UW Cancer Center Johnson Creek
- University of Wisconsin Hospital and Clinics
Arms of the Study
Arm 1
Experimental
Treatment (combination chemotherapy)
Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.