Clinical trial · Interventional
TMC (Topotecan, Cyclophosphamide and Melphalan) for Multiple Myeloma
Phase II Study of High-Dose Topotecan, Cyclophosphamide and Melphalan for the Treatment of Multiple Myeloma
NCT01039025CI-TRIAL-00035679completedPhase 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)
To determine the efficacy of high-dose topotecan, cyclophosphamide and melphalan in patients with Multiple Myeloma.
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 |
|---|---|---|---|
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Peripheral Blood Stem Cells | Other | — | UNRESOLVED |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TMC
- description
- Topotecan, Melphalan, and Cyclophosphamide
- interventionNames
- Drug: Topotecan
- Drug: Cyclophosphamide
- Drug: Melphalan
- Other: Peripheral Blood Stem Cells
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- Within 180 days after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with intermediate or high tumor mass multiple myeloma with responsive or primary refractory disease; and patients with responsive or refractory relapse. 2. Physiological age \</= 70. 3. Zubrod performance status \< 3. 4. Life expectancy greater than 12 weeks. 5. Left ventricular ejection fraction \>/= 50%. 6. No uncontrolled arrythmias or symptomatic cardiac disease. 7. FEV1, FVC and DLCO \>/= 50%. 8. No symptomatic pulmonary disease. 9. Serum creatinine \< 1.5 mg/dL. 10. Serum bilirubin \< 2x upper limit of normal. 11. No evidence of chronic or active hepatitis or cirrhosis. 12. Patient is not pregnant. 13. Patients or guardian able to sign informed consent. 14. No active CNS disease. 15. Platelet count \> 100K. Exclusion Criteria: 1\) N/A
References
Publications (0)
Data not yet available
No reference posted for this study.