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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Procedure: auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide; Procedure: Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI

• Registration Number: NCT00777998
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-14
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-23
• Primary Completion: 2018-04-17
• Study Completion: 2021-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide	Auto-Auto Tandem stem cell Transplantation plus maintenance therapy with Thalidomide
A	Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI	Auto-Allo Tandem Stem cell Transplantation plus maintenance therapy with Thalidomide and DLI

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of acute GvHD	day +100 after allogeneic stem cell transplantation
Treatment related mortality	four years after allogeneic stem cell transplantation
cumulative incidence of relapse	four years after Tandem stem cell transplantation
Toxicity of conditioning regimen and of maintenance therapy	Throughout conditioning regimen and maintenance therapy
Incidence of chronic GvHD	at one year and at two years after allogeneic stem cell transplantation
Disease related mortality	four years after allogeneic stem cell transplantation
overall survival	four years after allogeneic stem cell transplantation

Trial Locations

Locations (20)

Deutsche Klinik für Diagnostik; 🇩🇪 Wiesbaden, Germany

Universitätsklinikum Dresden; 🇩🇪 Dresden, Germany

Charité; 🇩🇪 Berlin, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Universitätsklinikum Greifswald; 🇩🇪 Greifswald, Germany

Universitätsklinikum Halle (Saale); 🇩🇪 Halle (Saale), Germany

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

Asklepios Klinik Altona; 🇩🇪 Hamburg, Germany

Universitätsklinikum Marburg; 🇩🇪 Marburg, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Universitätsklinikum Göttingen; 🇩🇪 Göttingen, Germany

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Klinikum Frankfurt (Oder) GmbH; 🇩🇪 Frankfurt (Oder), Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Horst Schmidt Kliniken GmbH; 🇩🇪 Wiesbaden, Germany