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Auto-Allo Tandem Stem Cell Transplantation for Patients With Multiple Myeloma

NCT00777998 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2023-10-27

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Nicolaus Kroeger, Prof. Dr. · University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-14
Primary Completion
2018-04-17
Completion
2021-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00777998 on ClinicalTrials.gov