NCT00561743

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_2 multiple-myeloma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
Last Updated

June 21, 2011

Status Verified

April 1, 2010

Enrollment Period

1.5 years

First QC Date

November 19, 2007

Last Update Submit

June 7, 2011

Conditions

Multiple Myeloma

Keywords

Multiple myelomaresponse rateperipheral stem cell transplantsafetytolerability

Outcome Measures

Primary Outcomes (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 Outcomes (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).

Interventions

Bortezomib + pegylated liposomal doxorubicin HCl + dexamethasoneDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Myeloma

Interventions

BortezomibDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Janssen-Ortho Inc. Clinical Trial

    Janssen-Ortho Inc., Canada

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 21, 2007

Study Start

November 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

June 21, 2011

Record last verified: 2010-04