Clinical trial · Interventional
Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma
Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma
NCT01617213CI-TRIAL-00010907AMM-2011terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study is no longer needed as recent data have answered the primary hypotheses for this study.
Summary
Brief summary (as posted)
This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2) with autologous PBSC transplant.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Maintenance Lenalidomide After Melphalan
- interventionNames
- Drug: Melphalan
- Drug: Lenalidomide
Primary outcomes (1)
- measure
- Event Free Survival
- timeFrame
- 3 years
- description
- Duration of time until patient experiences an event (recurrence, relapse or death)
Secondary outcomes (5)
- measure
- Disease Response
- timeFrame
- 2 years
- description
- Number of patients that have complete and very good partial responses.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Must be 18 to 75 years of age. * ECOG performance status of 0, 1 or 2. * Patients who have a history of another malignant disorder are eligible, provided that they have not received active therapy for 5 years. Patients with basal cell and squamous cell skin cancers are eligible. * Patients who are pregnant are ineligible. * Patients must furnish written informed consent and HIPAA authorization for release of personal health information. * Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments. * Patients must be HIV and HTLV-I,-II antibody sero-negative. * Patients must have adequate visceral organ function Exclusion Criteria: * Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, or a cumulative anthracycline exposure in excess of 550 mg/m2 Adriamycin (doxorubicin) unless the gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction. * Patients are ineligible if they are receiving any other investigational agents.
References
Publications (0)
Data not yet available
No reference posted for this study.