Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Stem Cell Transplantation, Thalidomide, DLI
Brief summary
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.
Interventions
PROCEDUREAuto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI
\*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
PROCEDUREauto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide
\*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)
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | four years after Tandem stem cell transplantation |
Secondary
| Measure | Time frame |
|---|---|
| Treatment related mortality | four years after allogeneic stem cell transplantation |
| Incidence of acute GvHD | day +100 after allogeneic stem cell transplantation |
| Incidence of chronic GvHD | at one year and at two years after allogeneic stem cell transplantation |
| overall survival | four years after allogeneic stem cell transplantation |
| cumulative incidence of relapse | four years after Tandem stem cell transplantation |
| Disease related mortality | four years after allogeneic stem cell transplantation |
| Toxicity of conditioning regimen and of maintenance therapy | Throughout conditioning regimen and maintenance therapy |
Countries
Germany
Outcome results
None listed