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Trial record 22 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

A Study Assessing Safety and Effectiveness of BORTEZOMIB Combination Therapy (Bortezomib + Doxorubicin Hydrochloride + Dexamethasone) in Previously Untreated Multiple Myeloma Patients

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: NCT00561743
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : June 21, 2011
Information provided by:
Janssen-Ortho Inc., Canada

Brief Summary:
The purpose of this study is to determine whether doxorubicin HCL liposome injection, bortezomib, and Dexamethasone in combination, are effective in previously untreated multiple myeloma patients. Bortezomib inhibits the function of proteasomes, a novel mechanism of action.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bortezomib + pegylated liposomal doxorubicin HCl + dexamethasone Phase 2

Detailed Description:
This was a single-arm, open-label, Phase II multi-centre study in Canada only. A total of 50 newly diagnosed multiple myeloma patients who were eligible for stem cell transplant were targeted for recruitment to this study. Combination doxorubicin HCL liposome injection, bortezomib and dexamethasone induction therapy was given for 4 cycles in preparation for stem cell collection and transplant. As remission status after induction and prior to the first or second auto-transplant has been shown to be the major determinant of both event free and overall survival in multiple myeloma patients, the goal has been to improve response rates through the use of various combinational approaches. As such, the objective of the present study was to test the hypothesis that treatment with this regimen could result in a higher complete + near complete response rate (CR + nCR) prior to stem cell transplant, than obtained with current regimens, and then to confirm the response rate post-transplant. Safety was evaluated using adverse event reportings, clinical laboratory tests and tests for cardiac function (multiple-gated acquisition scan/echocardiogram and electrocardiogram). Four 21-day cycles of combination induction therapy consisting of 1.3 mg/m2 bortezomib (given i.v. Days 1, 4, 8, 11) + 30 mg/m2 Doxil/Caelyx (given i.v. Day 4) + 40 mg Dex (given po Days 1-4, 8-11, 15-18 Cycle 1 only; Days 1-4 Cycles 2-4).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Assess the Safety and Efficacy of DBd Combination Therapy (DOXIL/CAELYX) [Doxorubicin HCL Liposome Injection], VELCADE [Bortezomib] and Dexamethasone) for Previously Untreated Multiple Myeloma Patients
Study Start Date : November 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Primary Outcome Measures :
  1. The primary endpoint was complete response (CR) and near complete response rate (nCR) post induction therapy (i.e. 4 cycles of therapy). Each cycle consisted of 21 days.

Secondary Outcome Measures :
  1. The secondary endpoints included time to best response, assessment of peripheral blood stem cells harvesting ( 3 weeks post cycle 4 day 21) and engraftment (within 4 weeks of mobilization), CR post-engraftment, QoL and safety (every cycle).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients with newly diagnosed multiple myeloma (MM) requiring therapy for whom stem cell transplantation is considered appropriate
  • Normal left ventricular ejection fraction
  • Able to give voluntary written informed consent
  • Female patients agree to use acceptable method for contraception

Exclusion Criteria:

  • Diagnosis of smoldering multiple myeloma (asymptomatic MM with absence of lytic bone lesions)
  • Renal insufficiency related to the monoclonal protein
  • Diagnosis of Waldenström's disease
  • Previous treatment for MM (excepting emergency use of a short course dexamethasone, radiation received > 30 days before study enrolment, plasmapheresis for treatment of clinically significant hyperviscosity syndrome > 30 days before trial enrolment)
  • Major surgery within 30 days before entry
  • Peripheral neuropathy or neuropathic pain Grade 2 or higher within 14 days of trial enrolment
  • Uncontrolled or severe cardiovascular disease (including myocardial infarction within 6 months prior to enrollment
  • NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, cardiac amyloidosis, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities)
  • Other malignancy within the past 5 years prior to enrolment (except for non-active basal cell or non-metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or Stage 1 carcinoma of the cervix
  • Known HIV seropositivity or active hepatitis A, B, or C infection
  • Use of any investigational drug within 30 days prior to enrolment in the trial
  • Medical or psychiatric condition that could interfere with trial participation
  • History of hypersensitivity or allergic reaction attributable to compounds containing boron, mannitol or doxorubicin.

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): NCT00561743

Sponsors and Collaborators
Janssen-Ortho Inc., Canada
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Study Director: Janssen-Ortho Inc. Clinical Trial Janssen-Ortho Inc., Canada

Layout table for additonal information Identifier: NCT00561743     History of Changes
Other Study ID Numbers: CR010927
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: April 2010

Keywords provided by Janssen-Ortho Inc., Canada:
Multiple myeloma
response rate
peripheral stem cell transplant

Additional relevant MeSH terms:
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Hemostatic Disorders
Liposomal doxorubicin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
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