Phase
Condition
Bone Neoplasm
Cancer/tumors
Cancer
Treatment
Dexamethasone
Bortezomib
Daratumumab
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 to 70 years of age, inclusive.
- Must have a new diagnosis of MM as per IMWG criteria.
- Measurable disease
- Newly diagnosed and treatment-naïve participants for whom high-dose therapy andautologous stem cell transplantation is part of the intended treatment plan.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Clinical laboratory values meeting the required criteria during screening and ≤3 daysprior to receiving first study treatment dose.
- Adequate bone marrow function.
- Adequate liver function.
- Adequate renal function.
- A female of childbearing potential (FOCBP) must have two negative serum or urinepregnancy tests at screening including within 24 hours of the start of studytreatment.
- Willing to practicing at least 1 highly effective method of contraception starting 4weeks prior to start of study treatment, while receiving study treatment includingduring any dose interruptions, and for at least 3 months after the last dose of anycomponent of the study treatment.
Exclusion
Exclusion Criteria:
- Prior or current systemic therapy or ASCT for any plasma cell dyscrasia, with theexception of emergency use of a short course (equivalent of dexamethasone 40 mg/dayfor a maximum 4 days) of corticosteroids before treatment.
- History of allogenic stem cell transplantation or prior organ transplant requiringimmunosuppressive therapy.
- Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by theNational Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)Version 5.
- Myelodysplastic syndrome or any malignancy within 24 months of signing consent. Theonly exceptions are malignancies treated within the last 24 months that are consideredcompletely cured.
- Plasmapheresis ≤28 days of approval.
- Radiation therapy for treatment of plasmacytoma ≤14 days of approval of enrollment.
- Forced Expiratory Volume in 1 second (FEV1) <50% of predicted normal.
- Concurrent medical or psychiatric condition or disease.
- Myocardial infarction ≤6 months of enrollment, or an unstable or uncontrolleddisease/condition related to or affecting cardiac function.
- Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG)abnormalities.
- Allergy, hypersensitivity, or intolerance to boron or mannitol, corticosteroids,monoclonal antibodies or human proteins, or the excipients of daratumumab,lenalidomide, bortezomib or dexamethasone.
- Pregnant or breast-feeding females
Study Design
Connect with a study center
Innsbruck Medical University
Innsbruck,
AustriaSite Not Available
Ordensklinikum Linz
Linz,
AustriaActive - Recruiting
Clinic Ottakring
Vienna,
AustriaSite Not Available
Medical University of Vienna
Vienna,
AustriaSite Not Available
Universitätsklinikum Hamburg - Eppendorf
Hamburg,
GermanyActive - Recruiting
Klinikum rechts der Isar (MRI) der Technischen Universität München Department of Internal Medicine III (Hematology/Oncology) Munchen
München,
GermanySite Not Available
University Hospital of Alexandroupolis
Alexandroupolis,
GreeceActive - Recruiting
Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
Athens,
GreeceActive - Recruiting
St Savvas Cancer Hospital
Athens,
GreeceActive - Recruiting
Theagenion Cancer Hospital
Thessaloníki,
GreeceActive - Recruiting
AOU Ospedali Riuniti di Ancona
Ancona,
ItalyActive - Recruiting
ASST Papa Giovanni XXIII Hospital
Bergamo,
ItalyActive - Recruiting
A.O.U. di Bologna - Policlinico S. Orsola Malpighi
Bologna,
ItalySite Not Available
A.O.Spedali Civili di Brescia
Brescia,
ItalyActive - Recruiting
A.O.U. Careggi - Firenze
Firenze,
ItalyActive - Recruiting
A.O.U. Policlinico S. Martino - Ematologia
Genova,
ItalySite Not Available
Novara Hospital
Novara,
ItalyActive - Recruiting
Policlinico S. Matteo Fondazione IRCCS - Pavia
Pavia,
ItalyActive - Recruiting
AUSL-IRCCS di Reggio Emilia Arcispedale S. Maria Nuova
Reggio Emilia,
ItalyActive - Recruiting
Ospedale "Infermi" di Rimini
Rimini,
ItalyActive - Recruiting
Ematologia IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo
San Giovanni Rotondo,
ItalyActive - Recruiting
A.O. S. Santa Maria Hospital Institute of Oncohematology Terni
Terni,
ItalySite Not Available
A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U
Torino, 10126
ItalyActive - Recruiting
Ospedale S. Maria della Misericordia di Udine
Udine,
ItalySite Not Available
Amsterdam Medical Center
Amsterdam,
NetherlandsSite Not Available
Rijnstate
Arnhem,
NetherlandsActive - Recruiting
Amphia ziekenhuis
Breda,
NetherlandsSite Not Available
University Medical Center Groningen
Groningen,
NetherlandsSite Not Available
Dijklander ziekenhuis
Purmerend,
NetherlandsActive - Recruiting
Erasmus University Medical Center Rotterdam
Rotterdam,
NetherlandsSite Not Available
Maasstad Ziekenhuis
Rotterdam,
NetherlandsActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.