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

Conditions: Multiple Myeloma

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 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

Keywords: ms-mrd