Clinical trial · Interventional
Total Marrow Irradiation and High-dose Melphalan for Double Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma
Efficacy and Safety of Double Autologous Hematopoietic Stem Cell Transplantation With Sequential Use of Total Marrow Irradiation and High-dose Melphalan in Multiple Myeloma
NCT01665014CI-TRIAL-00007842unknownPhase 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)
The purpose of this study is to evaluate if the use total marrow irradiation (TMI) as a sole preparation for the first autologous hematopoietic stem cell transplantation (autoHSCT) followed by high-dose melphalan used prior to second autoHSCT is safe and effective in patients with multiple myeloma (MM).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Total marrow irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Total marrow irradiation
- description
- Double autologous hematopoietic stem cell transplantation using TMI and HD-Mel
- interventionNames
- Radiation: Total marrow irradiation
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- three years
Secondary outcomes (1)
- measure
- Rate of complete and very good partial responses
- timeFrame
- six months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-65 years * Diagnosis of multiple myeloma * PR, VGPR or CR at inclusion * Performance status WHO 0-1 * Written informed consent Exclusion Criteria: * Organ dysfunction: elevated ALT, AST, bilirubin, AF; creatinine \>1.5 upper normal limit; LVEF \<45% * Active infection * Unstable diabetes * Psychiatric diseases * History of high-dose chemotherapy or irradiation * Second malignancy * Pregnancy
References
Publications (1)
- BACKGROUNDSomlo G, Spielberger R, Frankel P, Karanes C, Krishnan A, Parker P, Popplewell L, Sahebi F, Kogut N, Snyder D, Liu A, Schultheiss T, Forman S, Wong JY. Total marrow irradiation: a new ablative regimen as part of tandem autologous stem cell transplantation for patients with multiple myeloma. Clin Cancer Res. 2011 Jan 1;17(1):174-82. doi: 10.1158/1078-0432.CCR-10-1912. Epub 2010 Nov 3. PMID 21047977