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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

Phase 2
18 Years
70 Years
Not Enrolling
Multiple Myeloma

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Trial Information

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

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).

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Janssen-Ortho Inc. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Ortho Inc., Canada


United States: Institutional Review Board

Study ID:




Start Date:

November 2005

Completion Date:

May 2007

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • response rate
  • peripheral stem cell transplant
  • safety
  • tolerability
  • Multiple Myeloma
  • Neoplasms, Plasma Cell