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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

NOT_RECRUITINGPhase 2Sponsored by Stichting European Myeloma Network
No longer actively recruiting
PhasePhase 2
SponsorStichting European Myeloma Network
Started2023-11-23
Est. completion2024-12
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06189833

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.

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
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

Conditions2

CancerMultiple Myeloma

Interventions4

BortezomibDaratumumabDexamethasoneLenalidomide

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