Phase 3
Completed N=225
A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma
Source: ClinicalTrials.gov NCT00097981 ↗Enrolled (actual)
225
Serious AEs
46.8%
Results posted
Nov 2008
Primary outcomePrimary: Complete Response Rate: Number of Participants Who Achieved a Complete Response — 5; 8 Participants — p=0.49
Summary
The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response Rate: Number of Participants Who Achieved a Complete Response |
5; 8 | 0.49 |
| SECONDARY Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) |
81; 76 | 0.42 |
| SECONDARY Time to 1st Response |
44; 58 | 0.42 |
| SECONDARY Time to Progression |
584; 408 | 0.5162 |
| SECONDARY Overall Survival: Number of Participants Died Due to Any Cause |
21; 22 | 0.93 |
| SECONDARY Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow) |
30; 28 | — |
| SECONDARY Engraftment: Number of Participants Who Underwent Engraftment |
25; 25 | — |
Eligibility Criteria
Inclusion Criteria
- Previously untreated, histologically confirmed multiple myeloma (per International Myeloma Working Group [IMWG] criteria
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- Adequate absolute neutrophil count (ANC), platelet count and hemoglobin
- Adequate serum calcium
- Enrollment in System for Thalidomide Education and Prescribing Safety Program (S.T.E.P.S.)
Exclusion Criteria
- No treatment with dexamethasone for multiple myeloma
- No peripheral neuropathy of Grade 2 or higher
- No Left Ventricular Ejection Fraction (LVEF) of less than 45 percentage
- No history of life-threatening thromboembolic events of any kind (ie, myocardial infarction, pulmonary embolism, stroke or others), within 1 year before enrollment in the study
- No deep vein thrombosis (DVT) within 1 year of enrollment
- No current anticoagulation for DVT
Data sourced from ClinicalTrials.gov (NCT00097981). 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.