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

NCT ID: NCT00366106

Last Updated: 2012-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2011-03-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bortezomib

Patients will be treated with bortezomib at 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days (cycle).

Intervention Type: DRUG

dexamethasone

Dexamethasone tablets will be given at 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days (cycle).

Intervention Type: DRUG

doxorubicin HCl liposome

Patients will receive intravenous doxorubicin HCl liposome injection given at 30 mg/m\^2 on Day 4 every 28 days (cycle).

Intervention Type: DRUG

Other Intervention Names

Velcade; Decadron; Doxil

Eligibility Criteria

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performance of any study-relates procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Accelerated Community Oncology Research Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnetta Blakely, MD

Role: PRINCIPAL_INVESTIGATOR

Accelerared Community Oncology Research Network, Inc.

Locations

Wilshire Oncology Medical Group, Inc.

La Verne, California, United States

Medical Oncology & Hematology

Waterbury, Connecticut, United States

Advanced Medical Specialties

Miami, Florida, United States

Northeast Georgia Cancer Care

Athens, Georgia, United States

Augusta Oncology Associates, PC

Augusta, Georgia, United States

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, United States

North Idaho Cancer Center

Coeur d'Alene, Idaho, United States

Oncology-Hematology Associates, P.A.

Clinton, Maryland, United States

Hematology Oncology Centers of the Northern Rockies, PC

Billings, Montana, United States

Arena Oncology Associates

Lake Success, New York, United States

Tri-County Hematology and Oncology Associates

Canton, Ohio, United States

Mid Ohio Oncology/Hematology, Inc.

Columbus, Ohio, United States

Lancaster Cancer Center, Ltd.

Lancaster, Pennsylvania, United States

The West Clinic

Memphis, Tennessee, United States

Cancer Specialists of Tidewater, Ltd.

Chesapeake, Virginia, United States

Countries

United States

Other Identifiers

ACORN ALJBMM0502

Identifier Type: -

Identifier Source: org_study_id