NCT00777998

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
PROCEDURE	Auto-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
PROCEDURE	auto-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)

Timeline

• Start date: 2008-10-14
• Primary completion: 2018-04-17
• Completion: 2021-06-01
• First posted: 2008-10-23
• Last updated: 2023-10-27

Locations

20 sites across 1 country: Germany