Clinical trial · Interventional
Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma
Phase III Study of Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma
NCT00892346CI-TRIAL-00022072suspendedPhase 3ClinicalTrials.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): No avaliability of melphlan in mainland China
Summary
Brief summary (as posted)
The clinical trial is to evaluate the efficacy of single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200 mg/m2 followed by thalidomide maintenance in patients with newly-diagnosed myeloma after receiving 4-6 cycles of induction chemotherapy consisting of vincristin,adriamycin and dexamethasone (VAD) or thalidomide/dexamethasone between 18 to 65 years.
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 |
|---|---|---|---|
| Single ASCT with Thalidomide maintenance | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single ASCT with Thalidomide maintenance
- description
- Single ASCT followed by Thalidomide maintenance: 1. patients recieved 4-6 cycles of standard VAD chemotherapy or Thalidomide/dexamethasone as induction therapy 2. CTX+G-SCF mobilization to collecetd PBSC 3. Patiens recieved Mel 200 as conditioning followed by Thalidomide 100mg maintenance
- interventionNames
- Procedure: Single ASCT with Thalidomide maintenance
Primary outcomes (1)
- measure
- response rate: CR/nCR/VGPR
- timeFrame
- 6 months after auto-PBSCT
Secondary outcomes (3)
- measure
- overall survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Man or woman between age 18-65 with newly diagnosed Multiple Myeloma for whom stem cell transplantation is considered appropriate * Measurable serum and/or urinary paraprotein * European Cooperative Oncology Group performance status 0-3 * Serum bilirubin \< 1.5x the upper limit of normal (ULN) * Serum alanine transaminase (ALT)/aspartate transaminase values \< 2.5 x ULN * Subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study Exclusion criteria: * Woman of child bearing potential * Non-secretory MM * Serum creatinine \> 400 Micromol/l after initial resuscitation * patients with previous Grade 2-4 peripheral neuropathy * Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug * Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or III-IV heart failure
References
Publications (5)
- BACKGROUNDChang JE, Juckett MB, Callander NS, Kahl BS, Gangnon RE, Mitchell TL, Longo WL. Thalidomide maintenance following high-dose melphalan with autologous stem cell support in myeloma. Clin Lymphoma Myeloma. 2008 Jun;8(3):153-8. doi: 10.3816/CLM.2008.n.018. PMID 18650178
- BACKGROUNDAbdelkefi A, Ladeb S, Torjman L, Othman TB, Lakhal A, Romdhane NB, Omri HE, Elloumi M, Belaaj H, Jeddi R, Aissaoui L, Ksouri H, Hassen AB, Msadek F, Saad A, Hsairi M, Boukef K, Amouri A, Louzir H, Dellagi K, Abdeladhim AB; Tunisian Multiple Myeloma Study Group. Single autologous stem-cell transplantation followed by maintenance therapy with thalidomide is superior to double autologous transplantation in multiple myeloma: results of a multicenter randomized clinical trial. Blood. 2008 Feb 15;111(4):1805-10. doi: 10.1182/blood-2007-07-101212. Epub 2007 Sep 17. PMID 17875806
- BACKGROUNDHarousseau JL, Moreau P. Evolving role of stem cell transplantation in multiple myeloma. Clin Lymphoma Myeloma. 2005 Sep;6(2):89-95. doi: 10.3816/CLM.2005.n.034. PMID 16231846
- BACKGROUNDSpencer A, Prince HM, Roberts AW, Prosser IW, Bradstock KF, Coyle L, Gill DS, Horvath N, Reynolds J, Kennedy N. Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure. J Clin Oncol. 2009 Apr 10;27(11):1788-93. doi: 10.1200/JCO.2008.18.8573. Epub 2009 Mar 9. PMID 19273705
- BACKGROUNDKumar A, Kharfan-Dabaja MA, Glasmacher A, Djulbegovic B. Tandem versus single autologous hematopoietic cell transplantation for the treatment of multiple myeloma: a systematic review and meta-analysis. J Natl Cancer Inst. 2009 Jan 21;101(2):100-6. doi: 10.1093/jnci/djn439. Epub 2009 Jan 13. PMID 19141779