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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Ortho Inc., Canada
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin

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.