Study Stopped
Study was closed to enrollment when it became clear that enrollment was too slow to complete full enrollment target within time frame allowed.
Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma
A Phase II, Open Label Study Evaluating an Alternative Schedule of Velcade/Dexamethasone Plus Doxil in the Treatment of Multiple Myeloma
1 other identifier
interventional
32
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 multiple-myeloma
Started Jul 2006
Typical duration for phase_2 multiple-myeloma
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 16, 2006
CompletedFirst Posted
Study publicly available on registry
August 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
April 5, 2012
CompletedApril 6, 2012
April 1, 2012
4.7 years
August 16, 2006
September 26, 2011
April 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-emergent Peripheral Neuropathy
Every 4 weeks from start of treatment until end of treatment
Secondary Outcomes (3)
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
Relative Dose Intensity of Bortezomib
Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)
Interventions
Patients will be treated with bortezomib at 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days (cycle).
Dexamethasone tablets will be given at 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days (cycle).
Patients will receive intravenous doxorubicin HCl liposome injection given at 30 mg/m\^2 on Day 4 every 28 days (cycle).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Wilshire Oncology Medical Group, Inc.
La Verne, California, 91750, United States
Medical Oncology & Hematology
Waterbury, Connecticut, 06708, United States
Advanced Medical Specialties
Miami, Florida, 33176, United States
Northeast Georgia Cancer Care
Athens, Georgia, 30607, United States
Augusta Oncology Associates, PC
Augusta, Georgia, 30901, United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, 30060, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, 83814, United States
Oncology-Hematology Associates, P.A.
Clinton, Maryland, 20735, United States
Hematology Oncology Centers of the Northern Rockies, PC
Billings, Montana, 59101, United States
Arena Oncology Associates
Lake Success, New York, 11042, United States
Tri-County Hematology and Oncology Associates
Canton, Ohio, 44718, United States
Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43215, United States
Lancaster Cancer Center, Ltd.
Lancaster, Pennsylvania, 17605, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Cancer Specialists of Tidewater, Ltd.
Chesapeake, Virginia, 23320, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was closed to enrollment when it became clear that enrollment was too slow to complete the planned enrollment target of 45 patients within the time frame allowed. Response rate was unable to be assessed due to missingness of required data.
Results Point of Contact
- Title
- Vice President of Scientific Affairs
- Organization
- Accelerated Community Oncology Research Network, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Johnetta Blakely, MD
Accelerared Community Oncology Research Network, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2006
First Posted
August 18, 2006
Study Start
July 1, 2006
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 6, 2012
Results First Posted
April 5, 2012
Record last verified: 2012-04