Acute Myeloid Leukemia (AML)
HOVON-150
|
Title in German |
Behandlung mit Ivosidenib oder Enasidenib in Kombination mit intensiver Chemotherapie für Patienten mit bislang unbehandelter akuter myeloischer Leukämie (AML) oder bislang unbehandeltem vorangeschrittenem myelodysplastischem Syndrom (MDS-EB2) mit IDH1- oder IDH2-Mutation. |
|
Title in English |
A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy HOVON150AML |
|
Descriptioin |
Ziel dieser Studie ist eine Verbesserung des Behandlungsergebnisses der Therapie bei AML und MDS-EB2, beides bösartige Erkrankungen des Knochenmarks. Die Standardbehandlung gegen diese Erkrankungen ist eine Chemotherapie. Diese Patienten haben eine besondere Unter-Form der Erkrankung des Knochenmarks, weil in ihren Leukämiezellen im genetischen Material (DNA) ein spezifischer Fehler aufgetreten ist. Diesen Fehler bezeichnen wir als IDH1 oder IDH2 Mutation (Mutation = Veränderung der DNA), die zu Veränderungen bestimmter Stoffe in den Leukämiezellen führt. Diese veränderten Stoffe spielen bei der Entstehung von Leukämie und für das Überleben von Leukämiezellen eine wichtige Rolle. Ivosidenib ist ein Medikament, welches die veränderte Form von IDH1 in den Zellen hemmt. Enasidenib ist ein Medikament, welches die veränderte Form von IDH2 in den Zellen hemmt. Studien haben gezeigt, dass Ivosidenib und Enasidenib bei Patienten mit AML und MDS mit einer IDH1- oder einer IDH2-Mutation, bei denen die Krankheit nach vorheriger Chemotherapie zurückgekehrt ist, sicher sind. Bei einigen dieser Patienten konnte die Leukämie durch die Behandlung kontrolliert werden. Aufgrund der Ergebnisse dieser Studien wurden beide Medikamente in den USA für die Behandlung von Patienten mit AML und einer IDH1- oder einer IDH2-Mutation bereits zugelassen, bei denen die Krankheit nach vorheriger Behandlung mit Standardmedikamenten zurückgekehrt ist oder bei denen die Krankheit auf Standardmedikamente nicht angesprochen hat. Ivosidenib und Enasidenib sind in der Schweiz noch nicht zugelassen. Wir möchten nun die Wirksamkeit und Sicherheit von Ivosidenib und Enasidenib bei Patienten mit AML oder MDS-EB2 und einer IDH1- oder einer IDH2-Mutation untersuchen, die für diese Erkrankung bislang noch nicht behandelt wurden. Dabei möchten wir herausfinden, ob sich die Krankheit durch die Gabe des neuen Medikaments zusätzlich zur Standardbehandlung mit Chemotherapie wirksamer und länger kontrollieren lässt. |
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Phase/Biobank/ect. |
Phase 3 |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
aktiv seit 27.01.2021 - IDH 2 Rekrutierung abgeschlossen. IDH 1 bleibt offen. |
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BASEC Nummer |
2019-01281 |
|
KOFAM |
SNCTP000003541 |
|
WHO-Register-Nummer |
NCT03839771 |
|
Insel-Nummer |
4138 |
MP0533-CP101
|
Title in German |
Eine Studie mit MP0533 bei Patienten mit Blutkrebs |
|
Title in English |
A phase 1/2a, first-in-human, open-label, multicenter study of MP0533 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndrome with excess blasts-2 (MDS-EB2) |
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Description |
This study examines the study drug MP0533, which is being used in patients for the first time. Only patients diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) can take part in the study. MP0533 is designed to selectively bind to and kill cancer cells in the blood and bone marrow. It is expected to activate the body's immune system and trigger an immune response against the cancer to kill the cancer cells. Therefore, MP0533 offers a novel and innovative treatment option to be tested in humans. MP0533 has been shown to be safe in animal studies. Treatment with MP0533 aims to address the high unmet medical need for patients with recurrent or difficult-to-treat leukemia or myelodysplastic syndrome. In this study, we examine how safe the new study drug MP0533 is and how well it works. We are testing MP0533 at various dosages to define the safest and most efficient dosing regimen of study drug MP0533 for future studies. We also want to learn more about the distribution and concentration of the study drug in the blood and bone marrow and how it affects the body, its effect on the cancer cells, and the ability of the study drug to trigger an unwanted immune response in the body. The study is a multicenter international study. The participating centers are located in Europe (Netherlands and Switzerland). Two locations in Switzerland were selected to take part in the present clinical study. |
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Phase/Biobank/ect. |
1/2a |
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Head of Clincial Trial |
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Study-Nurse |
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Back-up |
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Back-up |
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Status |
temp. closed for patient recruitment since 21.04.2024 |
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BASEC Nummer |
2022-01615 |
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KOFAM |
SNCTP000005268 |
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EudraCT No. |
EUCTR2022-002432-31 |
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WHO-Register-Nummer |
|
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Insel-Nummer |
5294 |
Myelodysplastic Syndromes (MDS)
IMerge – GRN163L
|
Titel in German |
Eine Studie zur Beurteilung von Imetelstat (GRN163L) bei transfusionsabhängigen Patienten mit Myelodysplastischem Syndrom (MDS) der IPSS-Risikoklassen niedrig oder intermediär 1, das rezidiviert/refraktär gegenüber einer Behandlung mit einer Erythropoese-stimulierenden Substanz (ESA) ist |
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Titel in English |
A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) that is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment |
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Description |
Dies ist eine randomisierte, doppelblinde, placebokontrollierte Phase 3 Studie zum Vergleich der Wirksamkeit von Imetelstat versus Placebo, hinsichtlich Unabhängigkeit von Erythrozyten-Transfusionen. |
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Phase/Biobank/etc. |
Phase 2/3 |
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Studienleitung |
|
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Study-Nurse |
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Back-up |
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Status |
active, not recruiting |
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BASEC Nummer |
2020-02056 |
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KOFAM |
SNCTP000005028 |
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WHO-Register-Nummer |
NCT02598661 |
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Insel-Nummer |
4732 |
LUSPLUS-Studie
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Title in German |
Eine open-label, einarmige Phase-IIIb-Studie zur Bewertung der Wirksamkeit und Sicherheit von Luspatercept bei Patienten mit MDS mit niedrigem Risiko und ringsideroblastischem Phänotyp (MDS-RS) |
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Title in English |
A phase IIIb, open-label, single arm study to evaluate the efficacy and safety of luspatercept in patients with lower-risk MDS and ring-sideroblastic phenotype (MDS-RS) |
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Description |
The study aims to compare 70 non-del(5q) LR-MDS patients. ESAs refractory/relapsed/intolerant/ineligible or refractory/relapsed to HMAs or LEN will be included and receive treatment with luspatercept. |
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Phase |
3b |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
|
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Status |
aktive, recruiting |
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BASEC-Nummer |
2022-00877 |
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Kofam-Nummer |
SNCTP000005315 |
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WHO-Register-Nummer |
NCT05181592 |
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Insel-Nummer |
5328 |
"STIMULUS-MDS2" Trial
|
Title in German |
Eine randomisierte, doppelblinde, placebokontrollierte Phase III multizentrische Studie von Azacitidin mit oder ohne MBG453 zur Behandlung von Patienten mit mittleren, hohen oder sehr Hochrisiko-Myelodysplastisches Syndrom (MDS) gemäß IPSS-R, oder chronische myelomonozytische Leukämie-2 (CMML-2) |
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Title in English |
A randomized, double-blind, placebo-controlled phase III multi-center study of azacitidine with or without MBG453 for the treatment of patients with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) |
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Description |
This randomized, double-blind, placebo-controlled phase 3 study examines the effectiveness and safety of the checkpoint inhibitor MBG453 (TIM3 antibody) in combination with azacytidine in patients with high-risk MDS in first-line therapy. |
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Phase/Biobank/ect. |
Phase 3 |
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Head Clinical Trial |
|
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Study-Nurse |
|
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Back-up |
|
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Status |
active, not recruiting |
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BASEC Nummer |
2020-00463 |
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KOFAM |
SNCTP000003767 |
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WHO-Register-Nummer |
NCT04266301 |
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Insel-Nummer |
4547 |
Myeloproliferative Neoplasms (MPN)
t-MN
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Title in German |
Therapiebedingte myeloische Neoplasien nach zytotoxischer Behandlung: Risikobewertung, Patientencharakterisierung und prognostische Faktoren |
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Title in English |
Therapy-related myeloid neoplasms after cytotoxic treatment: risk assessment, patients characterization and prognostic factors |
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Descpription |
The study takes advantage of the Swiss Personalized Health Network initiative (SPHN), and in particular the Swiss Personalized Oncology network (SPO), to screen a large population of patients (more than 100,000) that have received chemotherapy and/or radiotherapy at four university hospitals in Switzerland. After screening, we expect to find 100 - 200 t-MN cases that will be used to discover new insights on the risks of developing t-MNs and the profile of t-MN patients. After local validation and data completion for t-MN cases, we will calculate t-MN risk and describe t-MN patient characteristics and outcomes. |
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Head Clinical Trial |
|
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Study nurse |
|
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Back-up |
|
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Status |
active, not recruiting |
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BASEC-Nummer |
2023-00475 |
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Kofam-Nummer |
|
|
WHO-Register-Nummer |
|
|
Insel-Nummer |
5547 |
Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Hodgkin Lymphoma (HL)
CLL 17
|
Title in German |
Klinische multizentrische, randomisierte, prospektive, open-label Phase 3 Studie mit Ibrutinib-Monotherapie versus zeitlich befristet Venetoclax plus Obinutuzumab versus zeitlich befristet Venetoclax plus Ibrutinb bei Patienten mit bisher unbehandelter chronischer lymphatischer Leukämie (CLL) |
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Title in English |
A phase 3 multicentre, randomized, prospective, open-label trial of Ibrutinib monotherapy versus fixed-duration Venetoclax plus Obinutuzumab versus fixed-duration Venetoclax plus Ibrutinib in patients with previously untreated chronic lymphocytic leukaemia (CLL) |
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Description |
Past studies have demonstrated the superiority of BCRi and venetoclax over chemoimmunotherapy in previously untreated CLL/SLL. However, these therapies have not yet been directly compared with each other. Of particular interest is the comparison of purely oral treatments against therapies with parenteral administration of antibodies as well as the comparison of long-term therapy leading to intolerance or progression against temporary therapy. In this study, three treatment arms, randomized 1:1:1, are compared against each other: |
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- Ibrutinib (I): monotherapy until intolerance or progression, |
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- Venetoclax+Obinutuzumab (VG): 6 cycles of venetoclax+obinutuzumab + 6 cycles of venetoclax, |
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- Venetoclax+Ibrutinib (VI): 3 cycles of ibrutinib, 12 cycles of venetoclax+ibrutinib. |
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Patients with previously untreated CLL/SLL with an indication for treatment according to iwCLL criteria are included. The primary endpoint is progression-free survival. Key secondary endpoints include response, minimal residual disease and overall survival. |
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Phase/Biobank etc. |
Phase 3 |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
active, not recruiting |
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BASEC Nummer |
2021-01861 |
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KOFAM |
SNCTP000004689 |
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WHO-Register-Nummer |
NCT04608318 |
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Insel-Nummer |
5025 |
MK-1026-003
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Title in German |
Eine Phase 2-Studie zur Evaluation der Wirksamkeit und Verträglichkeit von MK-1026 bei Patienten mit malignen hämatologischen Neoplasien |
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Title in English |
A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies |
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Description |
MK-1026 (Nemtabrutinib) ist ein oraler, reversibler, nicht-kovalenter ATP kompetitiver Inhibitor der BTK. Das Medikament hemmt die BTK unabhängig von C481 und ist daher sowohl bei Wildtyp als auch bei C481 mutierter BTK aktiv. In dieser Phase 2-Studie wird die Wirksamkeit (primärer Endpunkt: OR) und Verträglichkeit von MK-1026 in 8 Kohorten mit rezidivierter oder refraktärer CLL oder NHL untersucht: |
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A: CLL/SLL rezidiviert oder refraktär nach Vortherapie mit einem kovalenten, irreversiblen BTKi, einem BCL2i und einem PI3Ki, |
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B: CLL/SLL rezidiviert oder refraktär nach Vortherapie mindestens einer Vortherapie und BTKi-naiv, |
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C: CLL/SLL mit 17p Deletion rezidiviert oder refraktär nach mindestens einer Vortherapie, |
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D: Richter-Tansformation rezidivert oder refraktär nach mindestens einer Vortherapie (für die Richter-Transformation), |
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E: MCL rezidiviert oder refraktär nach Chemoimmunotherapie und einem kovalenten irreversiblen BTKi, |
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F: MZL (inklusive splenisches, nodales und extranodales MZL) rezidiviert oder refraktär nach Chemoimmunotherapie und einem kovalenten irreversiblen BTKi, |
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G: FL rezidiviert oder refraktär nach Chemoimmunotherapie, Immunmodulatoren (z.B. Lenalidomid + Rituximab) und einen PI3Ki, |
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H: WM rezidiviert oder refraktär nach Chemoimmunotherapie oder einen kovalenten irreversiblen BTKi. |
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Phase/Biobank/etc. |
Phase 2 |
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Head Clinical Trial |
|
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Study-Nurse |
|
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Back-up |
|
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Status |
active, recruiting |
|
BASEC Nummer |
2022-00139 |
|
KOFAM |
SNCTP000004864 |
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WHO-Register-Nummer |
NCT04728893 |
|
Insel-Nummer |
5093 |
VeRVe
|
Title in German |
Beobachtungsstudie zum Gebrauch von Venetoclax bei Patienten mit chronischer lymphatischer Leukämie (CLL) unter real-life Bedingungen in Österreich, Deutschland und der Schweiz |
|
Title in English |
Observational study of the use of venetoclax in patients with chronic lymphocytic leukemia (CLL) under real-life setting in Austria, Germany, and Switzerland |
|
Description |
This observational study examines the use of venetoclax in the approved indications in patients with chronic lymphocytic leukemia (CLL) under real-life conditions. |
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Venetoclax is administered as part of clinical routine. Clinical and laboratory data on tolerability and effectiveness will be collected. |
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In addition, molecular genetic studies from blood samples will be carried out to assess the clonal evolution of CLL cells, the TP53 clone size and minimal residual disease under venetoclax. The primary endpoint is best response at 12 months. |
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Phase/Biobank/etc. |
|
|
Head Clinical Trial |
|
|
Study-Nurse |
|
|
Back-up |
|
|
Status |
active, not recruiting |
|
BASEC Nummer |
2018-01541 |
|
KOFAM |
|
|
WHO-Register-Nummer |
NCT03342144 |
|
Insel-Nummer |
3882 |
EMN30 MajesTEC-4
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Title in German |
Phase-3-Studie mit Teclistamab in Kombination mit Lenalidomid im Vergleich zu Lenalidomid allein bei Teilnehmern mit neu entdecktem Knochenmarkkrebs (Multiples Myelom) als Erhaltungstherapie nach Transplantation körpereigener Stammzellen |
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Title in English |
Phase 3 Study of Teclistamab in Combination with Lenalidomide versus Lenalidomide Alone in Participants with NDMM as Maintenance Therapy Following ASCT” |
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Description |
This study is intended to further improve the treatment options for cancer that originates in the plasma cells of the bone marrow. Called multiple myeloma, it is caused by a growth of abnormal plasma cells in the bone marrow. The main aim is to investigate how well the addition of teclistamab to the standard treatment of lenalidomide works. For comparison, one experimental group is treated with teclistamab and lenalidomide and another group is treated with lenalidomide only. Since existing therapies usually delay the progression of the disease, standard treatment is also referred to as maintenance therapy. Maintenance therapy follows autologous stem cell transplantation. Teclistamab is a body defense substance (antibodies) that can bind to and kill malignant cells of multiple myeloma. The planned study will be conducted at multiple locations in different countries. In total, around 1,020 patients worldwide will take part in the study. The study is organized by the European Myeloma Network (EMN) and financed by the Janssen company. The study will last a total of 10 years (2 years of treatment and 8 years of long-term observations). For the study, data is continuously collected from the treated patients. Patients will be randomly assigned to one of the two treatment groups. Both patients and investigators know which treatment is being administered. Patients will be invited for a series of examinations such as bone marrow and blood tests. This study will not enroll patients who, for example, have received prior BCMA-directed therapy (BCMA means B cell maturation antigen, a protein on the cell surface), radiation therapy within 14 days before this study, a history of allogeneic stem cell transplantation, or have myelodysplastic syndrome. |
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Phase/Biobank/ect. |
3 |
|
Head Clinical Trial |
|
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Study-Nurse |
|
|
Study-Nurse |
|
|
Study-Nurse |
|
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Status |
no further patients can be included at this time: 20.11.2023 |
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BASEC Nummer |
2022-00496 |
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KOFAM |
SNCTP000005086 |
|
EudraCT No. |
EUCTR2021-002531-27 |
|
Insel-Nummer |
5230 |
Sanofi IONA-MM OBS16577
|
Title in German |
Eine prospektive, nicht-interventionelle, multinationale Beobachtungsstudie mit Isatuximab bei Patienten mit rezidivierendem und/oder refraktärem multiplem Myelom (RRMM) |
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Title in English |
A prospective, non-interventional, multinational, observational study with isatuximab in patients with relapsed and/or refractory multiple myeloma (RRMM) |
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Phase |
Beobachtungsstudie |
|
Description |
This study aims to understand the efficacy, safety and quality of life in patients with relapsed and/or refractory multiple myeloma (also referred to as “RRMM”) who are prescribed isatuximab as part of routine care. This study was commissioned (paid for) by Sanofi Aventis Groupe (referred to herein as “Sanofi” or “Sponsor”). A non-interventional study is a research study designed to collect data on the use and effects of a particular treatment over time. If you take part in the study, your normal care will continue unchanged. This means that everyday clinical practice is observed. You will receive care according to your normal routine treatment. The decision about treatment is the responsibility of your doctor in consultation with you. This study will not affect the normal care you receive. |
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Head Clinical Trial |
|
|
Study-Nurse |
|
|
Status |
open since 10.06.2021 |
|
BASEC Nummer |
2021-00347 |
|
KOFAM |
|
|
WHO-Register-Nummer |
|
|
Insel-Nummer |
4791 |
TreoMel Trial (IIT)
|
Title in German |
Vergleich von Treosulfan mit Melphalan gegen Melphalan alleine bei einer hochdosierten Chemotherapie vor autologer Transplantation bei Patienten mit einem Multiplen Myelom |
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Title in English |
comparing treosulfan and melphalan with melphalan alone as conditioning regimen for autologous stem cell transplantation (ASCT) in myeloma patients |
|
Description |
Aim of the study: You have previously been treated with medication for myeloma disease. Your doctor has informed you in detail about the type of myeloma disease and the entire treatment protocol. Your treatment now also includes an intensive therapy phase, the so-called high-dose chemotherapy with the transplantation of your own (autologous) stem cells (autologous stem cell transplantation). Stem cells are precursor cells of normal blood cells. These stem cells normally develop into red blood cells (erythrocytes), white blood cells (leukocytes) and blood platelets (thrombocytes) in the bone marrow. After chemotherapy and treatment with growth factors (G-CSF), stem cells can pass from the bone marrow into the blood. Such stem cells can then be removed from the blood through your veins and collected (stem cell collection). Such a stem cell collection will be carried out on you. This is followed by particularly strong chemotherapy, a so-called high-dose chemotherapy, followed by an autologous (own) stem cell transplant. The purpose of such high-dose chemotherapy is to destroy any remaining myeloma cells as completely as possible. For several decades, autologous stem cell transplantation (ASCT) after high-dose chemotherapy (HDCT) has been the standard in first-line therapy for patients with multiple myeloma if they are sufficiently fit. Nevertheless, practically all patients develop a relapse of their myeloma disease even after this intensive therapy. Therefore, intensive efforts are being made to improve high-dose chemotherapy for this patient group. The present study at the Inselspital in Bern is intended to clarify in a 1:1 comparison whether additional administration of the drug treosulfan (Trecondi®) can improve the results of high-dose melphalan therapy. We would like to show that more myeloma patients can achieve the goal of complete remission. A total of 120 myeloma patients are needed, including 60 patients in each of the two treatment arms. The drug Trecondi® contains the active ingredient treosulfan. It is administered at a dose of 14 g/m2 as an infusion over 2 hours, for three days in a row. Selection: We are asking you because all people can take part who suffer from myeloma disease and, after standard chemotherapy for initial treatment (induction), high-dose chemotherapy with the transplantation of their own (autologous) stem cells (autologous stem cell transplantation) be received. Anyone suffering from multiple myeloma can take part in this study. They must also be between 18 and 75 years old. However, patients with myeloma who are not considered suitable for high-dose chemotherapy by their treating doctors due to other illnesses are not allowed to take part. |
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Phase |
2 |
|
Head Clinical Trial |
|
|
Study-Nurse |
|
|
Status |
open for patient recruitment since 06.06.2023 |
|
BASEC Nummer |
2022-01923 |
|
KOFAM |
SNCTP000005441 |
|
WHO-Register-Nummer |
NCT05636787 |
|
Insel-Nummer |
5441 |
EBMT CAR-T CIC221
EBMT CAR-T CIC221
|
Title in German |
Register der Europäischen Gesellschaft für Blut- und Knochenmarktransplantation (EBMT) |
|
Title in English |
Registry data processing framework |
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Description |
Purpose of the Registry The primary function of the Registry is to collect clinical data for research and to improve the safety and effectiveness of treatments and the quality of care. Ultimately, it's about saving the lives of patients with blood cancer and other life-threatening diseases. |
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Phase/Biobank/ect. |
Register |
|
Studienleiter |
|
|
Study-Nurse |
|
|
Status |
active since 15.07.2021 |
|
BASEC Nummer |
2021-00020 |
|
Insel-Nummer |
4812 |
CART Microbiome Study
CART Microbiome Study
|
Title in German |
Untersuchung des oro-intestinalen Mikrobioms bei PatientInnen mit lymphatischen Neoplasien und Chimeric Antigen Receptor (CAR)-T-Zell- Therapie |
|
Title in English |
Investigation of the oro-intestinal microbiome in patients with lymphatic neoplasms and chimeric antigen receptor (CAR) T-cell therapy |
|
Description |
In this research project we want to investigate whether the bacterial composition (microbiome) of the stool and oral flora predicts the response and complication rate of therapy with our own T cells, the so-called CAR T cell therapy, and thus as a predictor of the effects of CAR -T cell therapy can be used. |
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Head Clinical Trial |
|
|
Study-Nurse |
|
|
Status |
aktive since 03.06.2022 |
|
BASEC Nummer |
2022-00203 |
|
Insel-Nummer |
5154 |
TreoMel Trial (IIT)
|
Title in German |
Vergleich von Treosulfan mit Melphalan gegen Melphalan alleine bei einer hochdosierten Chemotherapie vor autologer Transplantation bei Patienten mit einem Multiplen Myelom |
|
Title in English |
comparing treosulfan and melphalan with melphalan alone as conditioning regimen for autologous stem cell transplantation (ASCT) in myeloma patients |
|
Description |
Aim of the study: You have previously been treated with medication for myeloma disease. Your doctor has informed you in detail about the type of myeloma disease and the entire treatment protocol. Your treatment now also includes an intensive therapy phase, the so-called high-dose chemotherapy with the transplantation of your own (autologous) stem cells (autologous stem cell transplantation). Stem cells are precursor cells of normal blood cells. These stem cells normally develop into red blood cells (erythrocytes), white blood cells (leukocytes) and blood platelets (thrombocytes) in the bone marrow. After chemotherapy and treatment with growth factors (G-CSF), stem cells can pass from the bone marrow into the blood. Such stem cells can then be removed from the blood through your veins and collected (stem cell collection). Such a stem cell collection will be carried out on you. This is followed by particularly strong chemotherapy, a so-called high-dose chemotherapy, followed by an autologous (own) stem cell transplant. The purpose of such high-dose chemotherapy is to destroy any remaining myeloma cells as completely as possible. For several decades, autologous stem cell transplantation (ASCT) after high-dose chemotherapy (HDCT) has been the standard in first-line therapy for patients with multiple myeloma if they are sufficiently fit. Nevertheless, practically all patients develop a relapse of their myeloma disease even after this intensive therapy. Therefore, intensive efforts are being made to improve high-dose chemotherapy for this patient group. The present study at the Inselspital in Bern is intended to clarify in a 1:1 comparison whether additional administration of the drug treosulfan (Trecondi®) can improve the results of high-dose melphalan therapy. We would like to show that more myeloma patients can achieve the goal of complete remission. A total of 120 myeloma patients are needed, including 60 patients in each of the two treatment arms. The drug Trecondi® contains the active ingredient treosulfan. It is administered at a dose of 14 g/m2 as an infusion over 2 hours, for three days in a row. Selection: We are asking you because all people can take part who suffer from myeloma disease and, after standard chemotherapy for initial treatment (induction), high-dose chemotherapy with the transplantation of their own (autologous) stem cells (autologous stem cell transplantation) be received. Anyone suffering from multiple myeloma can take part in this study. They must also be between 18 and 75 years old. However, patients with myeloma who are not considered suitable for high-dose chemotherapy by their treating doctors due to other illnesses are not allowed to take part. |
|
Phase |
2 |
|
Head Clinical Trial |
|
|
Study-Nurse |
|
|
Status |
open for patient recruitment since 06.06.2023 |
|
BASEC Nummer |
2022-01923 |
|
KOFAM |
SNCTP000005441 |
|
WHO-Register-Nummer |
NCT05636787 |
|
Insel-Nummer |
5441 |