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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00366106
Recruitment Status : Terminated (Study was closed to enrollment when it became clear that enrollment was too slow to complete full enrollment target within time frame allowed.)
First Posted : August 18, 2006
Results First Posted : April 5, 2012
Last Update Posted : April 6, 2012
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: bortezomib Drug: dexamethasone Drug: doxorubicin HCl liposome Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open Label Study Evaluating an Alternative Schedule of Velcade/Dexamethasone Plus Doxil in the Treatment of Multiple Myeloma
Study Start Date : July 2006
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Intervention Details:
    Drug: bortezomib
    Patients will be treated with bortezomib at 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days (cycle).
    Other Name: Velcade
    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).
    Other Name: Decadron
    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).
    Other Name: Doxil

Primary Outcome Measures :
  1. Incidence of Treatment-emergent Peripheral Neuropathy [ Time Frame: Every 4 weeks from start of treatment until end of treatment ]

Secondary Outcome Measures :
  1. Time to Progression (TTP) [ Time Frame: TTP was measured from day 1 of treatment until time of progression, assessed up to 40 months ]
  2. Number of Participants With Treatment Response [ Time Frame: 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.

  3. Relative Dose Intensity of Bortezomib [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00366106

United States, California
Wilshire Oncology Medical Group, Inc.
La Verne, California, United States, 91750
United States, Connecticut
Medical Oncology & Hematology
Waterbury, Connecticut, United States, 06708
United States, Florida
Advanced Medical Specialties
Miami, Florida, United States, 33176
United States, Georgia
Northeast Georgia Cancer Care
Athens, Georgia, United States, 30607
Augusta Oncology Associates, PC
Augusta, Georgia, United States, 30901
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States, 30060
United States, Idaho
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States, 83814
United States, Maryland
Oncology-Hematology Associates, P.A.
Clinton, Maryland, United States, 20735
United States, Montana
Hematology Oncology Centers of the Northern Rockies, PC
Billings, Montana, United States, 59101
United States, New York
Arena Oncology Associates
Lake Success, New York, United States, 11042
United States, Ohio
Tri-County Hematology and Oncology Associates
Canton, Ohio, United States, 44718
Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, United States, 43215
United States, Pennsylvania
Lancaster Cancer Center, Ltd.
Lancaster, Pennsylvania, United States, 17605
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
United States, Virginia
Cancer Specialists of Tidewater, Ltd.
Chesapeake, Virginia, United States, 23320
Sponsors and Collaborators
Accelerated Community Oncology Research Network
Millennium Pharmaceuticals, Inc.
Principal Investigator: Johnetta Blakely, MD Accelerared Community Oncology Research Network, Inc.

Responsible Party: Accelerated Community Oncology Research Network Identifier: NCT00366106     History of Changes
Other Study ID Numbers: ACORN ALJBMM0502
First Posted: August 18, 2006    Key Record Dates
Results First Posted: April 5, 2012
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by Accelerated Community Oncology Research Network:
Relapsed Multiple Myeloma
Refractory Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Liposomal doxorubicin
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal