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Phase 2 Completed N=74 Treatment

Combination Study of Revlimid®, Velcade® Dexamethasone and Doxil® (RVDD)for Newly Diagnosed Multiple Myeloma

Source: ClinicalTrials.gov NCT00724568 ↗
Enrolled (actual)
74
Serious AEs
4.1%
Results posted
Sep 2014
Primary outcomePrimary: Maximum Tolerated Dose (MTD) of Combination Therapy With VELCADE, Dexamethasone, and Doxil, (RVDD) — 25; 1.3; 20; 30 mg

Summary

This research study is evaluating an investigational combination of four drugs called Revlimid® (lenalidomide), Velcade® (bortezomib), Dexamethasone and Doxil® (RVDD) as a possible treatment for newly diagnosed multiple myeloma.

Outcome Measures

OutcomeResultp-value
PRIMARY
Maximum Tolerated Dose (MTD) of Combination Therapy With VELCADE, Dexamethasone, and Doxil, (RVDD)
25; 1.3; 20; 30
SECONDARY
The Percentage of Patients That Achieved Partial or Complete Response to Treatment.
96

Eligibility Criteria

Inclusion Criteria

  • At least 18 years of age at the time of consent
  • Measurable disease
  • All necessary baseline studies completed
  • LVEF (left ventricular ejection fraction) greater than or equal to 50 percent by MUGA (multigated acquisition scan) or ECHO (echocardiogram)
  • Must be able to adhere to study visit schedule

Exclusion

  • Greater than or equal to grade 2 peripheral neuropathy on clinical examination within 14 days of enrollment
  • Renal insufficiency
  • Evidence of mucosal or internal bleeding and/ or platelet refractory.
  • Absolute neutrophil count less than 1000 cells/mm^2 within 14 days of enrollment.
  • Acceptable labs
  • Concomitant medications that include corticosteroids
  • Myocardial infarction within 6 months prior to enrollment, uncontrolled angina, severe uncontrolled ventricular arrhythmias
  • Clinically relevant active infection or serious medical condition that places the subject at unacceptable risk
  • Any condition, including laboratory values that places the subject at an unacceptable risk
  • Another malignancy within 3 years of enrollment, with the exception of the complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy
  • Hypersensitivity to bortezomib, boron, or mannitol or any of the components of DOXIL
  • Female subject that is pregnant or breastfeeding.
  • Can not have received any other investigational drugs within 14 days of enrollment
  • Serious medical or psychiatric illness
  • Uncontrolled diabetes mellitus
  • Hypersensitivity to acyclovir or similar antiviral drug
  • POEMS (plasma cell dyscrasia with polyneuropathy)
  • Known HIV
  • Known hepatitis B or C
  • Known intolerance to steroid therapy
  • Known hypersensitivity to required prophylactic mediations
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00724568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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