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

This study is currently recruiting participants.

Verified January 2009 by Universitätsklinikum Hamburg-Eppendorf

Sponsor:

Information provided by:

Universitätsklinikum Hamburg-Eppendorf

ClinicalTrials.gov Identifier:

NCT00777998

First received: October 22, 2008

Last updated: January 9, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 22, 2008

Last Updated Date

January 9, 2009

Start Date ^ICMJE

August 2008

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00777998 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of acute GvHD [ Time Frame: day +100 after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
Incidence of chronic GvHD [ Time Frame: at one year and at two years after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
Toxicity of conditioning regimen and of maintenance therapy [ Time Frame: Throughout conditioning regimen and maintenance therapy ] [ Designated as safety issue: Yes ]
cumulative incidence of relapse [ Time Frame: four years after Tandem stem cell transplantation ] [ Designated as safety issue: Yes ]
Disease related mortality [ Time Frame: four years after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
Treatment related mortality [ Time Frame: four years after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
overall survival [ Time Frame: four years after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Autologous-Allogeneic Tandem Stem Cell Transplantation and Maintenance Therapy With Thalidomide/ DLI for Patients With Multiple Myeloma (MM) and Age < 55 Years: A Phase II-Study

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 >55 years, followed by maintenance therapy with low-dose Thalidomide and Donor Lymphocyte Infusions.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

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)

Study Arm (s)

Experimental: A
Auto-Allo Tandem Stem cell Transplantation plus maintenance therapy with Thalidomide and DLI

Intervention: Procedure: Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI
Active Comparator: B
Auto-Auto Tandem stem cell Transplantation plus maintenance therapy with Thalidomide

Intervention: Procedure: auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

220

Estimated Completion Date

August 2014

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Multiple Myeloma Stage II or III acc. to Salmon and Durie
Patient's age 18-55 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 > 56 years

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Nicolaus Kroeger, Prof. Dr.	+49-40-42803-5864	nkroeger@uke.uni-hamburg.de
Contact: Marion Heinzelmann	+49-40-42803-4188	mheinzel@uke.uni-hamburg.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00777998

Other Study ID Numbers ^ICMJE

Auto-Allo TSCT in MM

Has Data Monitoring Committee

Responsible Party

Prof. Dr. N. Kroeger, University Medical Center Hamburg-Eppendorf

Study Sponsor ^ICMJE

Universitätsklinikum Hamburg-Eppendorf

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Universitätsklinikum Hamburg-Eppendorf

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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