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

NCT ID: NCT00777998

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-14
• Study Completion Date: 2021-06-30

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: EXPERIMENTAL

Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI

Intervention Type: PROCEDURE

*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

B

Auto-Auto Tandem stem cell Transplantation plus maintenance therapy with Thalidomide

Group Type: ACTIVE_COMPARATOR

auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide

Intervention Type: PROCEDURE

*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)

Interventions

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

Intervention Type: 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)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolaus Kroeger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation

Locations

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, , Germany

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Asklepios Klinik Altona

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , 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, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 37941409 (View on PubMed)

Other Identifiers

Auto-Allo TSCT in MM

Identifier Type: -

Identifier Source: org_study_id