Status:
RECRUITING
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
Lead Sponsor:
Stichting European Myeloma Network
Collaborating Sponsors:
Janssen Pharmaceutica
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 transplantatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06189833
Start Date
November 23 2023
End Date
December 1 2025
Last Update
April 23 2024
Active Locations (31)
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1
Innsbruck Medical University
Innsbruck, Austria
2
Ordensklinikum Linz
Linz, Austria
3
Clinic Ottakring
Vienna, Austria
4
Medical University of Vienna
Vienna, Austria