NCT00344422

Brief Summary

The purpose of this study is to determine how well newly diagnosed multiple myeloma patients respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection) and Dexamethasone (VDD) versus the standard treatment of Vincristine, Doxorubicin and Dexamethasone (VAD).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P25-P50 for phase_3 multiple-myeloma

Timeline
Completed

Started Oct 2000

Shorter than P25 for phase_3 multiple-myeloma

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2006

Completed
Last Updated

June 10, 2011

Status Verified

April 1, 2010

First QC Date

June 23, 2006

Last Update Submit

June 8, 2011

Conditions

Multiple MyelomaMyelomaM-ProteinMyeloma Proteins

Keywords

AnthracyclinesLiposomesLiposomalVincristineDoxorubicinDexamethasonePegylated Liposomal DoxorubicinDOXILdrug resistant myeloma

Outcome Measures

Primary Outcomes (1)

  • To determine and compare the objective response rate (the percentage of patients who attain an Objective Status of Complete Remission, Remission or Partial Remission) for patients receiving VDD vs VAD.

Secondary Outcomes (1)

  • To evaluate and compare the clinical benefit of VDD vs VAD for the following measures: Hospitalization, Documented sepsis,Antibiotic use, Grade 3 or 4 neutropenia or neutropenic fever

Interventions

Vincristine, DOXIL (doxorubicin HCl liposomal injection), and Dexamethasone (VDD) vs. Vincristine, Doxorubicin and Dexamethasone (VAD)DRUG

Eligibility Criteria

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

You may qualify if:

  • Untreated multiple myeloma requiring treatment
  • Total cumulative dose of prior doxorubicin can not exceed 240 mg/m2
  • Must have measurable disease
  • Left Ventricular Ejection Fraction (LVEF) \>= 50 % determined by Multiple Gated Acquisition Scan (MUGA)
  • Karnofsky performance status of \>= 60%
  • Adequate bone marrow, liver and renal function
  • Disease-free from prior malignancies \>= 5 years with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control.

You may not qualify if:

  • Life expectancy of \>= 3 months
  • Pregnant or breast feeding
  • History of cardiac disease, with New York Heart Association Class II or greater, with congestive heart failure
  • or unstable angina, uncontrolled hypertension or cardiac arrythmias or myocardial infarction within the last 6 months
  • Uncontrolled diabetes mellitus or systemic infection
  • Nonsecretory myeloma, Monoclonal Gammopathy of Unknown Significance (MGUS) or smoldering myeloma
  • Confusion, disorientation, or history of psychiatric illness which may impair patient's ability to give informed consent
  • Prior chemotherapy to treat Multiple Myeloma
  • Prior radiotherapy to an area greater than 1/3 of the skeleton
  • Prior local radiotherapy within 1 week of treatment
  • Any investigational agent within 30 days of the first dose of treatment
  • Prior single agent dexamethasone (or another corticosteroid) to treat Multiple Myeloma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Rifkin RM, Gregory SA, Mohrbacher A, Hussein MA. Pegylated liposomal doxorubicin, vincristine, and dexamethasone provide significant reduction in toxicity compared with doxorubicin, vincristine, and dexamethasone in patients with newly diagnosed multiple myeloma: a Phase III multicenter randomized trial. Cancer. 2006 Feb 15;106(4):848-58. doi: 10.1002/cncr.21662.

    PMID: 16404741RESULT

Related Links

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

Vincristineliposomal doxorubicinDexamethasoneDoxorubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 26, 2006

Study Start

October 1, 2000

Study Completion

June 1, 2004

Last Updated

June 10, 2011

Record last verified: 2010-04