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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
221
\*Multiple myeloma * -\> Induction Therapy (max. 8 cycles) * -\> Registration of patient, stem cell mobilization, start of donor search * -\> Melphalan (200mg/qm) plus autologous PBSCT * -\> 2 months later: Melphalan plus allogeneic PBSCT * -\> day 120 after allogeneic PBSCT: Thalidomide, 100mg (max. 2 years or until progress or non-tolerable toxicity, respectively) * -\> day 180 after allogeneic PBSCT (if CsA discontinued): First DLI (1 x 10\^6 (MRD) or 5 x 10\^5 (MUD) CD3+ cells per kg BW) * -\> day 250 after allogeneic PBSCT: second DLI (if no signs of GvHD: dose escalation by 0,5 Log) * -\> Day 320 after allogeneic PBSCT: Third DLI (if no signs of GvHD: dose escalation by 0,5 Log) * -\> Further DLI depending on MRD-measurement
\*Multiple myeloma * -\> Induction Therapy (max. 8 cycles) * -\> Registration of patient, stem cell mobilization, start of donor search * -\> Melphalan (200mg/qm) plus autologous PBSCT * -\> if no donor available (max 4 weeks after autologous PBSCT) or if patients declines allogeneic PBSCT): 2 months: Melphalan (200mg/qm) plus autologous PBSCT * -\> day 120 after autologous PBSCT: Thalidomide, 100mg (max. 2 years or until progress or non-tolerable toxicity, respectively)
Klinikum Augsburg
Augsburg, Germany
Charité
Berlin, Germany
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.
Time frame: four years after Tandem stem cell transplantation
Incidence of acute GvHD
Time frame: day +100 after allogeneic stem cell transplantation
Incidence of chronic GvHD
Time frame: at one year and at two years after allogeneic stem cell transplantation
Toxicity of conditioning regimen and of maintenance therapy
Time frame: Throughout conditioning regimen and maintenance therapy
cumulative incidence of relapse
Time frame: four years after Tandem stem cell transplantation
Disease related mortality
Time frame: four years after allogeneic stem cell transplantation
Treatment related mortality
Time frame: four years after allogeneic stem cell transplantation
overall survival
Time frame: four years after allogeneic stem cell transplantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätsklinikum Dresden
Dresden, Germany
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Düsseldorf, Germany
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Erlangen, Germany
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Essen, Germany
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), Germany
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Göttingen, Germany
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Greifswald, Germany
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Halle, Germany
...and 10 more locations