Clinical trial · Interventional
Auto-Allo Tandem Stem Cell Transplantation for Patients With Multiple Myeloma
Autologous-Allogeneic Tandem Stem Cell Transplantation and Maintenance Therapy With Thalidomide/ DLI for Patients With Multiple Myeloma (MM) and Age < _60 Years: A Phase II-study
NCT00777998CI-TRIAL-00070847completedPhase 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 present study will be a multicenter, prospective phase II-study investigating safety and efficacy of the combination of auto-allo tandem stem cell transplantation in patients with multiple myeloma and age of \>\_60 years, followed by maintenance therapy with low-dose Thalidomide and Donor Lymphocyte Infusions.
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 |
|---|---|---|---|
| Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI | Procedure | — | UNRESOLVED |
| auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Auto-Allo Tandem Stem cell Transplantation plus maintenance therapy with Thalidomide and DLI
- interventionNames
- Procedure: Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Auto-Auto Tandem stem cell Transplantation plus maintenance therapy with Thalidomide
- interventionNames
- Procedure: auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide
Primary outcomes (1)
- measure
- Event-free survival 4 years after auto-allo/ auto-auto Tandem-SCT. Any of the following will be considered an endpoint event: recurrence or progression of primary disease, disease related mortality, or treatment related mortality.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Multiple Myeloma Stage II or III acc. to Salmon and Durie * Patient's age 18-60 years * Patient's written informed consent * Women and men capable of reproduction must agree to use adequate contraceptive measures (condom, IUD, oral contraceptives) until three months after termination of treatment * a maximum of eight chemotherapy cycles prior to registration (CR/ PR/ MR/ or PD) Exclusion Criteria: * More than eight chemotherapy cycles prior to registration * severe irreversible renal, hepatic, pulmonary or cardiac disease, such as * total bilirubin, SGPT or SGOT \> 3 times upper the normal level * Left ventricular ejection fraction \< 30 % * Creatinine Clearance \< 30 ml/min * DLCO \< 35 % and/or receiving supplementary continuous oxygen * Positive serology for HIV * Pregnant or lactating women * Participation in another trial at the time of registration * Preceding autologous stem cell transplantation * age \> 61 years
References
Publications (1)
- DERIVEDKroger N, Wulf G, Hegenbart U, Burchert A, Stelljes M, Gagelmann N, Brecht A, Kaufmann M, Muller L, Ganser A, Wolf D, Bethge W, Bornhauser M, Kiehl M, Wagner EM, Schmid C, Reinhardt HC, Kobbe G, Salwender H, Heinicke T, Kropff M, Heinzelmann M, Ayuk F, Trumper L, Neubauer A, Volp A, Kluychnikov E, Schonland S, Wolschke C. Autologous-allogeneic versus autologous tandem stem cell transplantation and maintenance therapy with thalidomide for multiple myeloma patients under 60 years of age: a prospective, phase II study. Haematologica. 2024 May 1;109(5):1469-1479. doi: 10.3324/haematol.2023.282920. PMID 37941409