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CompletedNCT00344422Updated Jun 10, 2011

Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

A Phase 3 interventional study of Vincristine, DOXIL (doxorubicin HCl liposomal injection), and Dexamethasone (VDD) vs. Vincristine, Doxorubicin and Dexamethasone (VAD) in Multiple Myeloma, Myeloma and M-Protein, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-10.

Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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).

Read the detailed description

This is a randomized, open label study comparing the efficacy, clinical benefit, toxicity and safety of the combination of Vincristine, DOXIL® (doxorubicin HCl liposome injection), and Dexamethasone (VDD) to the standard regimen of Vincristine, Doxorubicin and Dexamethasone (VAD) in patients with newly diagnosed multiple myeloma. Approximately 200 patients with newly diagnosed multiple myeloma will be randomized to receive either VDD or VAD. This study will 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. This study will also 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.

VDD: Vincristine 1.4 mg/m2 IV on Day 1; Doxil® 40 mg/m2 IV on Day 1; Dexamethasone 40 mg/day oral Days 1-4; VAD: Vincristine 0.4 mg/day continuous infusion Days 1-4; Doxorubicin 9.0 mg/m2/day continuous infusion Days 1-4; Dexamethasone 40 mg/day orally on Days 1-4; Every 28 days for 4 cycles

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Conditions studied

  • Multiple Myeloma
  • Myeloma
  • M-Protein
  • Myeloma Proteins

Keywords

  • Anthracyclines
  • Liposomes
  • Liposomal
  • Vincristine
  • Doxorubicin
  • Dexamethasone
  • Pegylated Liposomal Doxorubicin
  • DOXIL
  • drug resistant myeloma
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In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 198 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
198 participants (actual)

Interventions

  • DrugVincristine, DOXIL (doxorubicin HCl liposomal injection), and Dexamethasone (VDD) vs. Vincristine, Doxorubicin and Dexamethasone (VAD)
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What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 16404741 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00344422
Lead sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
First posted
Jun 26, 2006
Start date
Oct 2000
Completion
Jun 2004
Last update
Jun 10, 2011

Study contacts

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
study director · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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