Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

Registration Number: NCT00366106

Lead Sponsor: Accelerated Community Oncology Research Network

Brief Summary: The current study is being conducted to evaluate the possibility that a different schedule of bortezomib, doxorubicin HCl liposome, and dexamethasone might decrease the incidence of peripheral neuropathy yet maintain similar efficacy and allow maintenance of bortezomib dosing for a longer period.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 32

Inclusion Criteria

Patient is at least 18 years of age.
Patient has confirmed diagnosis of relapsed/refractory multiple myeloma with measurable disease by serum or urine. Measurable disease defined as monoclonal protein of ≥ 1g/dl on serum protein electrophoresis (SPEP) or > 200 mg urine M protein/ 24 hours
Patient has received at least 1 prior treatment regimen. (Prior treatment with bortezomib is allowed.)
Patient has ECOG ≤ 2
Patient provides voluntary written informed consent before performance of any study-relates procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Patients who have received prior high dose chemotherapy with stem cell support are eligible for this study.
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
Male subject agrees to use an acceptable method for contraception for the duration of the study.

Exclusion Criteria

Patient has a platelet count of < 50, 000 cells/mm³, within 14 days before enrollment.
Patient has an absolute neutrophil count (ANC) ≤ 750/mm³ within 14 days before enrollment.
Patient has a calculated or measured creatinine clearance of < 20 mL/min within 14 days before enrollment and/or serum creatinine ≥ 2.5 mg/dl.
Patient has hemoglobin < 7.5 g/dl.
Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
Myocardial infarction within 6 months prior to enrollment or has (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant.
Patient has received a total cumulative dosage of anthracyclines exceeding 550 mg/m2.
Patient has hypersensitivity to boron or mannitol.
Patient has history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of DOXIL.
Patient has clinically significant coexisting illness unrelated to myeloma.
Patient has uncontrolled diabetes.
Patient has plasma cell leukemia.
Patient has serum bilirubin > 1.5 x upper normal limit, alanine aminotransaminase (ALT), aspartate aminotransferase (AST) > 2.5 x upper normal limit (ULN), or alkaline phosphatase > 2.5 x ULN.
Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG)pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Patient has received other investigational drugs within 14 days before enrollment.
Patient has serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-emergent Peripheral Neuropathy	Every 4 weeks from start of treatment until end of treatment

Secondary Outcome Measures

Name	Time	Method
Time to Progression (TTP)	TTP was measured from day 1 of treatment until time of progression, assessed up to 40 months
Number of Participants With Treatment Response	Every 8 weeks from start of treatment until end of treatment	Complete Response (CR), Partial Response (PR), and Minor Response (MR) each required stable bone disease and normal calcium levels. CR also required 100% serum protein electrophoresis (SPEP) reduction, negative immunofixation (IF), 100% urine protein electrophoresis (UPEP)reduction, and \<5% plasma cells in bone marrow. PR also required \>=50% SPEP reduction, \>=90% UPEP reduction, and \>=50% reduction in plasma cells in bone marrow. MR also required \>=25% SPEP reduction, \>=50% UPEP reduction, and \> 25% reduction in plasma cells.
Relative Dose Intensity of Bortezomib	Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)	Relative dose intensity is defined as actual dose/scheduled dose. Bortezomib is administered on Days 1, 4, 15, and 18 every 28 days.

Trial Locations

Locations (15): Augusta Oncology Associates, PC
🇺🇸
Augusta, Georgia, United States
Northwest Georgia Oncology Centers, PC
🇺🇸
Marietta, Georgia, United States
Mid Ohio Oncology/Hematology, Inc.
🇺🇸
Columbus, Ohio, United States
Wilshire Oncology Medical Group, Inc.
🇺🇸
La Verne, California, United States
Advanced Medical Specialties
🇺🇸
Miami, Florida, United States
Medical Oncology & Hematology
🇺🇸
Waterbury, Connecticut, United States
Oncology-Hematology Associates, P.A.
🇺🇸
Clinton, Maryland, United States
Hematology Oncology Centers of the Northern Rockies, PC
🇺🇸
Billings, Montana, United States
The West Clinic
🇺🇸
Memphis, Tennessee, United States
Arena Oncology Associates
🇺🇸
Lake Success, New York, United States
Northeast Georgia Cancer Care
🇺🇸
Athens, Georgia, United States
Tri-County Hematology and Oncology Associates
🇺🇸
Canton, Ohio, United States
North Idaho Cancer Center
🇺🇸
Coeur d'Alene, Idaho, United States
Lancaster Cancer Center, Ltd.
🇺🇸
Lancaster, Pennsylvania, United States
Cancer Specialists of Tidewater, Ltd.
🇺🇸
Chesapeake, Virginia, United States