Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments auto-allo tandem sct and maintenance therapy with thalidomide/ dli, auto-auto tandem stem cell transplantation and maintenance therapy with thalidomide
Phase phase 2
Sponsor Universitätsklinikum Hamburg-Eppendorf
Start date August 2008
End date May 2017
Trial size 221 participants
Trial identifier NCT00777998, Auto-Allo TSCT in MM

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Auto-Allo Tandem Stem cell Transplantation plus maintenance therapy with Thalidomide and DLI
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
(Active Comparator)
Auto-Auto Tandem stem cell Transplantation plus maintenance therapy with Thalidomide
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)

Primary Outcomes

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.
time frame: four years after Tandem stem cell transplantation

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title 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
Principal investigator Nicolaus Kroeger, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf.