A study using new methods to monitor multiple myeloma in patients who are not yet treated, receiving treatment with a new anti-myeloma drug combination and either a stem cell transplant with continuation of the same anti-myeloma drug combination or followed by a different, novel treatment combination and no transplant - TAURUS
- Conditions
- Multiple Myeloma, Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505221-14-00
- Lead Sponsor
- Stichting European Myeloma Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
1.18 to 70 years of age, inclusive., 6.Clinical laboratory values meeting the following criteria during screening and =3 days prior to receiving first study treatment dose: Adequate bone marrow function: a. Hemoglobin =7.5 g/dL (=4.65 mmol/L; without prior red blood cell [RBC] transfusion =7 days before laboratory test; recombinant human erythropoietin use is permitted. b. Absolute neutrophil count (ANC) =1.0 x 10^9/L (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF or 14 days for pegylated-G-CSF); c. Platelet count =50 x 10^9/L if bone marrow is >50% involved in myeloma. Otherwise =75 x 10^9/L (without transfusion support or thrombopoietin receptor agonist =7 days before the laboratory test) Adequate liver function: a. Aspartate aminotransferase (AST) =2.5 x ULN (Upper Limit Normal); b. Alanine aminotransferase (ALT) =2.5 x ULN; c. Total bilirubin =1.5 x ULN (except in participants with congenital nonhemolytic hyperbilirubinemia, such as Gilbert syndrome, direct bilirubin =1.5 x ULN) Adequate renal function: a. Estimated creatinine clearance =30 mL/min. Creatinine clearance may be calculated using Cockcroft-Gault or a 24-hour urine collection. b. Corrected serum calcium =13.5 mg/dL (=3.4 mmol/L); or free ionized calcium =6.5 mg/dL (=1.6 mmol/L)., 2.Must have a new diagnosis of MM as per IMWG criteria., 3. Measurable disease by central lab defined by any of the following: a. Serum monoclonal protein (M-protein) levels =0.5 g/dL or urine M-protein levels = 200 mg/24 hours; b. Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin FLC =10 mg/dL (=100 mg/L) and abnormal serum immunoglobulin kappa/lambda FLC ratio., 4.Newly diagnosed and treatment-naïve participants for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan., 5.Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
1.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., 2.History of allogenic stem cell transplantation or prior organ transplant requiring immunosuppressive therapy., 3.Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCI-CTCAE Version 5., 4.Participants will be excluded if they have any of the following: a.Any ongoing myelodysplastic syndrome or B cell malignancy (other than multiple myeloma) b.Any history of malignancy, other than multiple myeloma, which is considered at high risk of recurrence requiring systemic therapy c.Any active malignancy (ie, progressing or requiring treatment change in the last 24 months prior to enrollment) other than multiple myeloma. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured: i.Non-muscle invasive bladder cancer (solitary Ta-papillary urothelial neoplasm of low malignant potential [PUNLMP] or low grade, <3 cm, no carcinoma in situ) ii.Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone iii.Noninvasive cervical cancer iv.Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ or history of localized breast cancer (anti-hormonal therapy is permitted) v.Localized prostate cancer (M0, N0) with a Gleason Score =7 a, treated locally only (radical prostatectomy/radiation therapy/focal treatment) vi.Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor’s medical monitor NOTE: In the event of any questions, consult with the sponsor’s medical monitor prior to enrolling a participant., 5.Plasmapheresis =28 days of approval., 6.Radiation therapy for treatment of plasmacytoma =14 days of approval of enrollment (palliative radiation for pain control secondary to lytic lesion is allowed =14 days of approval)., 7.Central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method