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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777998
• Other study ID #: Auto-Allo TSCT in MM
• Status: Completed
• Phase: Phase 2
• Start date: October 14, 2008
• Est. completion date: June 2021

Study information

• Verified date: October 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: June 2021
• Est. primary completion date: April 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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
• 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)

Locations

Country	Name	City	State
Germany	Klinikum Augsburg	Augsburg
Germany	Charité	Berlin
Germany	Universitätsklinikum Dresden	Dresden
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Universitätsklinikum Essen	Essen
Germany	Klinikum Frankfurt (Oder) GmbH	Frankfurt (Oder)
Germany	Universitätsklinikum Göttingen	Göttingen
Germany	Universitätsklinikum Greifswald	Greifswald
Germany	Universitätsklinikum Halle (Saale)	Halle (Saale)
Germany	Asklepios Klinik Altona	Hamburg
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum Marburg	Marburg
Germany	Universitätsklinikum Münster	Münster
Germany	Robert-Bosch-Krankenhaus	Stuttgart
Germany	Universitätsklinikum Tübingen	Tübingen
Germany	Deutsche Klinik für Diagnostik	Wiesbaden
Germany	Horst Schmidt Kliniken GmbH	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of acute GvHD		day +100 after allogeneic stem cell transplantation
Secondary	Incidence of chronic GvHD		at one year and at two years after allogeneic stem cell transplantation
Secondary	Toxicity of conditioning regimen and of maintenance therapy		Throughout conditioning regimen and maintenance therapy
Secondary	cumulative incidence of relapse		four years after Tandem stem cell transplantation
Secondary	Disease related mortality		four years after allogeneic stem cell transplantation
Secondary	Treatment related mortality		four years after allogeneic stem cell transplantation
Secondary	overall survival		four years after allogeneic stem cell transplantation