Phase
Condition
Multiple Myeloma
Lymphoproliferative Disorders
Leukemia
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Understand and voluntarily sign an informed consent form
- Patients willing and able to undergo autologous and allogeneic transplantation
- no previous systemic therapy for the treatment of multiple myeloma (dexamethasone at acumulative dose of 320 mg; plasmapheresis/dialysis without concomitant chemotherapy,local irradiation of bone lesions; and surgical intervention is accepted aspretreatment)
- Newly diagnosed multiple myeloma according to common diagnostic criteria includingpresence of CRAB and measurable disease parameters
- Cardiac ejection fraction (LVEF) of at least 50%
- Corrected DLCO of at least 50% ; alternatively pO2 [art.] of at least 70mmHg
- Karnofsky performance status of greater or equal to 50%
- adequate bone marrow function
- adequate serum chemistry values
- Use of adequate contraception for female subjects with childbearing potential and malesubjects
- Bone marrow sample available for analysis of molecular cytogenetics
- Able to administer low molecular-weight heparin as a prophylactic anticoagulationtherapy for the first three months(applicable for subjects randomized to RAD) and ableto administer ASS 100 mg/d (applicable for subjects randomized to VRD)
Exclusion
Exclusion Criteria:
- Any serious medical condition, laboratory abnormality, or psychiatric illness thatwould prevent the subject from signing the informed consent form
- Pregnant or lactating females
- Any condition, including the presence of laboratory abnormalities, which places thesubject at unacceptable risk
- History of myocardial infarction; NYHA Class III or IV heart failure, uncontrolledangina, severe uncontrolled ventricular arrhythmias; concomitant pericarditis orperi-/myocarditis
- Use of any other experimental drug or therapy within 28 days of baseline
- Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14days before enrollment
- Known intolerance of boron
- Hypersensitivity to acyclovir or similar anti-viral drug
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, insitu cervical, breast or prostate cancer
- HIV positive, active hepatitis B, C or D viral infection, known CMVreactivation/active infection, EBV reactivation/active infection or treponema palliduminfection
- Uncontrolled diabetes mellitus
- Non-secretory MM
- Clinically relevant active infection or serious co-morbid medical conditions
Study Design
Connect with a study center
Universitätsklinikum Aachen, Med. Klinik IV, Hämatologie u. Onkologie
Aachen, 52074
GermanySite Not Available
Schön Klinik Starnberger See, Hämatologie und Onkologie
Berg, 82335
GermanySite Not Available
Charité Campus Virchow-Klinikum, Hämatologie, Onkologie u. Tumorimmunologie
Berlin, 13353
GermanySite Not Available
Klinikum Bremen-Mitte gGmbH, Klinik für Innere Medizin I
Bremen, 28177
GermanySite Not Available
Universitätsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik I
Dresden, 01307
GermanySite Not Available
Universitätsklinikum Erlangen, Medizinische Klinik 5
Erlangen, 91054
GermanySite Not Available
Malteser Krankenhaus St. Franziskus-Hospital, medizinische Klinik I
Flensburg, 24939
GermanySite Not Available
Klinikum der Johann Woflgang Goethe Universität, Frankfurt am Mai
Frankfurt am Main, 60596
GermanySite Not Available
Klinikum Frankfurt (Oder) GmbH Medizinische Klinik I
Frankfurt/Oder, 15236
GermanySite Not Available
Universitätsklinikum Freiburg, Abteilung für Innere Medizin I
Freiburg, 79106
GermanySite Not Available
Universitätmedizin Greifswald, Klinik und Poliklinik für Innere Medizin C
Greifswald, 17475
GermanySite Not Available
St. Marien-Hospital gem. GmbHKna
Hamm, 59071
GermanySite Not Available
Universitätsklinikum des Saarlandes Innere Medizin I
Homburg/Saar, 66421
GermanySite Not Available
Klinikum der Friedrich-Schiller-Universität Jena, Klinikum für Innrere Medizin II
Jena, 07747
GermanySite Not Available
Städtisches Klinikum Karlsruhe Medizinische Klinik III, Abt. Hämatologie u. Onkologie
Karlsruhe, 76133
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein Campus Kiel, II. Med. Poliklinik
Kiel, 24105
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein, Medizinische Klinik und Poliklinik II im städtischen Krankenhaus Kiel
Kiel, 24116
GermanySite Not Available
Stiftungsklinikum Mittelrhein GmbH, Klinik für Innere Medizin
Koblenz, 56068
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Medizinische Klinik I
Lübeck, 23538
GermanySite Not Available
Universitätsmedizin Mannheim medizinische Klinik III
Mannheim, 68167
GermanySite Not Available
III. Med. Klinik und Poliklinik, Klinikum rechts der Isar der TU München
München, 81675
GermanySite Not Available
Klinikum Schwabing
München, 80804
GermanySite Not Available
Klinikum der Universität München-Großhadern
München, 81366
GermanySite Not Available
Universitätsklinikum Münster, Medizinische Klinik u. Poliklinik A
Münster, 48149
GermanySite Not Available
Klinikum Nürnberg Nord, 5. Medizinische LKinik, Onkologie/Hämatologie
Nürnberg, 90419
GermanySite Not Available
Klinikum Oldenburg GmbH, Klinik für Innere Medizin II
Oldenburg, 26133
GermanySite Not Available
Klinikum Ernst von Bergmann, Klinik für Hämatologie, Onkologie
Potsdam, 14467
GermanySite Not Available
Uniklinikum Regensburg, Abteilung für Hämatologie und internistische Onkologie
Regensburg, 93053
GermanySite Not Available
Robert-Bosch-Krankenhaus, Abt. Hämatologie, Onkologie u. Palliativmedizin
Stuttgart, 70376
GermanySite Not Available
Universitätsklinikum Ulm,Klinik für Innere Medizin III
Ulm, 89081
GermanySite Not Available
Schwarzwald-Baar Klinkum Villingen-Schwennigen GmbH
Villingen-Schwenningen, 78048
GermanySite Not Available
Dr. Horst Schmidt Kliniken, Klinik Innere Medizin III
Wiesbaden, 65199
GermanySite Not Available
Universitätsklinikum Wuerzburg, Medizinische Klinik II
Wuerzburg, 97080
GermanySite Not Available
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