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

This study has been completed.
Sponsor:
Information provided by:
Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:
NCT00561743
First received: November 19, 2007
Last updated: June 7, 2011
Last verified: April 2010
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: Bortezomib + pegylated liposomal doxorubicin HCl + dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Janssen-Ortho Inc., Canada:

Primary Outcome Measures:
  • 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:
  • 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).

Enrollment: 50
Study Start Date: November 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561743

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

No publications provided

ClinicalTrials.gov Identifier: NCT00561743     History of Changes
Other Study ID Numbers: CR010927
Study First Received: November 19, 2007
Last Updated: June 7, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Liposomal doxorubicin
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents

ClinicalTrials.gov processed this record on October 23, 2014