Clinical trial · Interventional
Liposomal Doxorubicin, Vincristine, & Dexamethasone Plus Arsenic Trioxide in Untreated Symptomatic Multiple Myeloma
Phase II Trial of Pegylated Liposomal Doxorubicin (Doxil), Vincristine, and Dexamethasone (DVd) in Combination With Arsenic Trioxide (Trisenox) in Untreated Patients With Symptomatic Multiple Myeloma
NCT00201695CI-TRIAL-00018228completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will assess the ability of Doxorubicin, Vincristine and Dexamethasone plus arsenic trioxide to achieve an overall response rate of greater than 60%.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arsenic Trioxide | Drug | Arsenic Trioxide | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxil® | Drug | Doxorubicin | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Assess the ability of DVd plus arsenic trioxide to achieve an overall response (complete and partial) rate in patients with untreated Multiple myeloma(MM)
- timeFrame
- 2004-2008
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have Multiple Myeloma * No prior chemotherapy, thalidomide, or corticosteroids treatments for Multiple Myeloma * ECOG performance status must be 0-2 Exclusion Criteria: * Resting left ventricular cardiac ejection fraction ≥50% by echo or MUGA scan. * QT interval ≥480 msec on baseline ECG. * No history of cardiac disease. * Pregnant or breast-feeding. * No history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil. * History of prior or concurrent malignancy or myelodysplasia.
References
Publications (1)
- RESULTHofmeister CC, Jansak B, Denlinger N, Kraut EH, Benson DM, Farag SS. Phase II clinical trial of arsenic trioxide with liposomal doxorubicin, vincristine, and dexamethasone in newly diagnosed multiple myeloma. Leuk Res. 2008 Aug;32(8):1295-8. doi: 10.1016/j.leukres.2007.10.020. Epub 2007 Dec 21. PMID 18082257