Auto-Allo Tandem Stem Cell Transplantation for Patients With Multiple Myeloma
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
1 other identifier
interventional
221
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Oct 2008
Longer than P75 for phase_2 multiple-myeloma
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2008
CompletedFirst Submitted
Initial submission to the registry
October 22, 2008
CompletedFirst Posted
Study publicly available on registry
October 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedOctober 27, 2023
October 1, 2023
9.5 years
October 22, 2008
October 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Incidence of acute GvHD
day +100 after allogeneic stem cell transplantation
Incidence of chronic GvHD
at one year and at two years after allogeneic stem cell transplantation
Toxicity of conditioning regimen and of maintenance therapy
Throughout conditioning regimen and maintenance therapy
cumulative incidence of relapse
four years after Tandem stem cell transplantation
Disease related mortality
four years after allogeneic stem cell transplantation
- +2 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALAuto-Allo Tandem Stem cell Transplantation plus maintenance therapy with Thalidomide and DLI
B
ACTIVE COMPARATORAuto-Auto Tandem stem cell Transplantation plus maintenance therapy with Thalidomide
Interventions
\*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
\*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)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Klinikum Augsburg
Augsburg, 86156, Germany
Charité
Berlin, 12203, Germany
Universitätsklinikum Dresden
Dresden, 01307, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Universitätsklinikum Essen
Essen, 45122, Germany
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), 15236, Germany
Universitätsklinikum Göttingen
Göttingen, 37075, Germany
Universitätsklinikum Greifswald
Greifswald, 17475, Germany
Universitätsklinikum Halle (Saale)
Halle, 06097, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsklinikum Marburg
Marburg, 35032, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Robert-Bosch-Krankenhaus
Stuttgart, 70376, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Deutsche Klinik für Diagnostik
Wiesbaden, 65191, Germany
Horst Schmidt Kliniken GmbH
Wiesbaden, 65199, Germany
Related Publications (1)
Kroger N, Wulf G, Hegenbart U, Burchert A, Stelljes M, Gagelmann N, Brecht A, Kaufmann M, Muller L, Ganser A, Wolf D, Bethge W, Bornhauser M, Kiehl M, Wagner EM, Schmid C, Reinhardt HC, Kobbe G, Salwender H, Heinicke T, Kropff M, Heinzelmann M, Ayuk F, Trumper L, Neubauer A, Volp A, Kluychnikov E, Schonland S, Wolschke C. Autologous-allogeneic versus autologous tandem stem cell transplantation and maintenance therapy with thalidomide for multiple myeloma patients under 60 years of age: a prospective, phase II study. Haematologica. 2024 May 1;109(5):1469-1479. doi: 10.3324/haematol.2023.282920.
PMID: 37941409DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolaus Kroeger, Prof. Dr.
University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2008
First Posted
October 23, 2008
Study Start
October 14, 2008
Primary Completion
April 17, 2018
Study Completion
June 1, 2021
Last Updated
October 27, 2023
Record last verified: 2023-10