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Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma
This study has been terminated.
Sponsors and Collaborators: Accelerated Community Oncology Research Network
Millennium Pharmaceuticals, Inc.
Information provided by: Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier: NCT00366106
  Purpose

The purpose of this research study is to see if the combination of Velcade and dexamethasone provides better response than other alternatives, and can be used longer as maintenance therapy for the treatment of multiple myeloma. In addition, this study is being conducted to see if using different schedules of the two study drugs might reduce peripheral neuropathy (pain and tingling in the hands and feet).


Condition Intervention Phase
Multiple Myeloma
Drug: bortezomib
Drug: Dexamethasone
Drug: doxorubicin HCl liposome
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II, Open Label Study Evaluating an Alternative Schedule of Velcade/Dexamethasone Plus Doxil in the Treatment of Multiple Myeloma

Further study details as provided by Accelerated Community Oncology Research Network:

Primary Outcome Measures:
  • To evaluate the incidence of treatment-emergent peripheral neuropathy and the TTP with an alternative schedule of bortezomib/dexamethasone plus doxorubicin HCl liposome injection in patients with refractory/relapsed multiple myeloma. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the response rate, the delivered relative dose intensity, and to explore measurement of quality of life (QoL) using the Patient Care Monitor (PCM). [ Time Frame: 4 to 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2006
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: bortezomib
    Patients will be treated with bortezomib at 1.3mg/m2 on Days 1,4,15,and 18 every 28 days(cycle).
    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).
    Drug: doxorubicin HCl liposome
    Patients will receive intravenous doxorubicin HCl liposome injection given at 30 mg/m2 on Day 4 every 28 days (cycle).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (see Section 7.4), 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 clinically significant.
  • Patient has received a total cumulative dosage of anthracyclines exceeding 550mg/m
  • Patient has hypersensitivity to boron or mannitol.
  • Patient has history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl components of DOXIL.
  • Patient has clinically significant coexisting illness unrelated to myeloma.
  • Patient has uncontrolled diabetes.
  • Patient has plasma cell leukemia.
  • Patients have 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366106

Locations
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
Augusta Oncology Associates, PC
Augusta, Georgia, United States, 30901
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States, 30060
Northeast Georgia Cancer Care
Athens, Georgia, United States, 30607
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.
Investigators
Principal Investigator: Johnetta Blakely, MD Accelerared Community Oncology Research Network, Inc.
  More Information

Responsible Party: Accelerated Community Oncology Research Network ( Cindy Lee, RN, MSN, CCRP )
Study ID Numbers: ACORN ALJBMM0502
Study First Received: August 16, 2006
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00366106  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Dexamethasone
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Doxorubicin
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Enzyme Inhibitors
Antibiotics, Antineoplastic
Hormones
Glucocorticoids
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009