Trial Title:
Phase 2 Study Applying MRD Techniques for Participants With Previously Untreated Multiple Myeloma Treated With D-VRd Prior To and After High-dose Therapy Followed by ASCT - TAURUS
NCT ID:
NCT06189833
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Lenalidomide
Bortezomib
Daratumumab
Conditions: Keywords:
MS-MRD
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Daratumumab
Description:
Daratumumab will be administered via a subcutaneous injection (SC)
Arm group label:
D-VRd + ASCT + DVRD
Other name:
JNJ-54767414
Intervention type:
Drug
Intervention name:
Bortezomib
Description:
Bortezomib will be administered via a subcutaneous injection (SC)
Arm group label:
D-VRd + ASCT + DVRD
Other name:
Velcade
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Lenalidomide will be administered orally
Arm group label:
D-VRd + ASCT + DVRD
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Dexamethasone will be administered orally
Arm group label:
D-VRd + ASCT + DVRD
Summary:
This is a multicenter, single arm, open-label, Phase 2 study in mutiple myeloma with
newly diagnosed and treatment-naïve participants for whom high-dose therapy and
autologous stem cell transplantation is part of the intended treatment plan. The study is
evaluating a technique called Mass Spectrometry Minimal Residual Disease (MS-MRD) using
blood samples and compares it with the minimal residual disease (MRD) technique using
bone marrow samples.
Criteria for eligibility:
Criteria:
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 and
autologous 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
days prior 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 urine
pregnancy tests at screening including within 24 hours of the start of study
treatment.
- Willing to practicing at least 1 highly effective method of contraception starting 4
weeks prior to start of study treatment, while receiving study treatment including
during any dose interruptions, and for at least 3 months after the last dose of any
component of the study treatment.
Exclusion Criteria:
- Prior or current systemic therapy or ASCT for any plasma cell dyscrasia, with the
exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day
for a maximum 4 days) of corticosteroids before treatment.
- History of allogenic stem cell transplantation or prior organ transplant requiring
immunosuppressive therapy.
- Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Version 5.
- Myelodysplastic syndrome or any malignancy within 24 months of signing consent. The
only exceptions are malignancies treated within the last 24 months that are
considered completely 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 uncontrolled
disease/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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Innsbruck Medical University
Address:
City:
Innsbruck
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Willenbacher
Facility:
Name:
Ordensklinikum Linz
Address:
City:
Linz
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Strassl
Facility:
Name:
Clinic Ottakring
Address:
City:
Vienna
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Schreder
Facility:
Name:
Medical University of Vienna
Address:
City:
Vienna
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Krauth
Facility:
Name:
Universitätsklinikum Hamburg - Eppendorf
Address:
City:
Hamburg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Weisel
Facility:
Name:
Klinikum rechts der Isar (MRI) der Technischen Universität München Department of Internal Medicine III (Hematology/Oncology) Munchen
Address:
City:
München
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Basserman
Facility:
Name:
University Hospital of Alexandroupolis
Address:
City:
Alexandroupolis
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Spanoudakis
Facility:
Name:
Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
Address:
City:
Athens
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Evangelos Terpos
Facility:
Name:
St Savvas Cancer Hospital
Address:
City:
Athens
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Pouli
Facility:
Name:
Theagenion Cancer Hospital
Address:
City:
Thessaloníki
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Katodritou
Facility:
Name:
AOU Ospedali Riuniti di Ancona
Address:
City:
Ancona
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Offidani
Facility:
Name:
ASST Papa Giovanni XXIII Hospital
Address:
City:
Bergamo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Rambaldi
Facility:
Name:
A.O.U. di Bologna - Policlinico S. Orsola Malpighi
Address:
City:
Bologna
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Zamagni
Facility:
Name:
A.O.Spedali Civili di Brescia
Address:
City:
Brescia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Belotti
Facility:
Name:
A.O.U. Careggi - Firenze
Address:
City:
Firenze
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Antonioli
Facility:
Name:
A.O.U. Policlinico S. Martino - Ematologia
Address:
City:
Genova
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Aquino
Investigator:
Last name:
Aquino
Email:
Principal Investigator
Facility:
Name:
Novara Hospital
Address:
City:
Novara
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Margiotta Casaluci
Facility:
Name:
Policlinico S. Matteo Fondazione IRCCS - Pavia
Address:
City:
Pavia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mangiacavalli
Facility:
Name:
AUSL-IRCCS di Reggio Emilia Arcispedale S. Maria Nuova
Address:
City:
Reggio Emilia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Gamberi
Facility:
Name:
Ospedale "Infermi" di Rimini
Address:
City:
Rimini
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Tosi
Facility:
Name:
Ematologia IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo
Address:
City:
San Giovanni Rotondo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Falcone
Facility:
Name:
A.O. S. Santa Maria Hospital Institute of Oncohematology Terni
Address:
City:
Terni
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Liberati
Facility:
Name:
A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mina
Facility:
Name:
Ospedale S. Maria della Misericordia di Udine
Address:
City:
Udine
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Patriarca
Facility:
Name:
Amsterdam Medical Center
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
van der Donk
Facility:
Name:
Rijnstate
Address:
City:
Arnhem
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Van der Spek
Facility:
Name:
Amphia ziekenhuis
Address:
City:
Breda
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
van der Klift
Investigator:
Last name:
van der Klift
Email:
Principal Investigator
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Roeloffzen
Facility:
Name:
Dijklander ziekenhuis
Address:
City:
Purmerend
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Klerk
Facility:
Name:
Erasmus University Medical Center Rotterdam
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Wester
Facility:
Name:
Maasstad Ziekenhuis
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Sprenger
Start date:
November 23, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Stichting European Myeloma Network
Agency class:
Other
Collaborator:
Agency:
Janssen Pharmaceutica
Agency class:
Industry
Source:
European Myeloma Network B.V.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06189833
