Phase 3
Completed N=646
Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
Source: ClinicalTrials.gov NCT00103506 ↗Enrolled (actual)
646
Serious AEs
35.4%
Results posted
May 2015
Primary outcomePrimary: Time to Progression (TTP) — 6.5; 9.3 Months
Summary
The purpose of this study is to evaluate time to progression, overall survival, response rate and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE vs. VELCADE monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression (TTP) |
6.5; 9.3 | — |
| SECONDARY Overall Survival |
30.8; 33.0 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
105; 120 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with multiple myeloma who have received at least 1 prior therapy and who have either responded and later had progressive disease or have progressed during their first therapy (primary refractory) are eligible for the study
- Patients who may have received prior doxorubicin but not more than a cumulative dose of 240 milligram per meter square (mg/m^2) doxorubicin, DOXIL, or the equivalent amount of another anthracycline (i.e., 1 mg doxorubicin = 1 mg DOXIL/CAELYX = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
- Must have normal cardiac function, as evidenced by a left LVEF within institutional normal limits.
Exclusion Criteria
- History of treatment with VELCADE or progressive disease while receiving an anthracycline-containing regimen
- No change in disease status during initial therapy
- No treatment for malignancy within past 5 yrs (other than multiple myeloma) or progressive disease while receiving anthracycline-containing regimen
- Non-secretory disease
- Myocardial infarct within past 6 months
- No major surgery in past 30 days.
Data sourced from ClinicalTrials.gov (NCT00103506). 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.