STUDY COMPARING TWO STANDARD TREATMENTS IN AUTOLOGOUS STEM CELL TRANSPLANTATION INELIGIBLE POPULATION AFFECTED BY MULTIPLE MYELOMA (Dara-VMP vs Dara-Rd)

Phase 1

• Conditions: ewly diagnosed MM patients >= 65 years old or ineligible for autologous stem cell transplant; MedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-512049-17-00
• Lead Sponsor: niversita' Degli Studi Di Torino

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-12
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Patients has given voluntary written informed consent before the performance of any study related procedure, 1.2.1) Clonal bone marrow plasma cell percentage =60% (clonality should be established by showing ?/?-light-chain restriction on flow cytometry, immunohistochemistry, or immunofluorescence. Bone marrow plasma cell percentage should preferably be estimated from a core biopsy specimen; in case of a disparity between the aspirate and core biopsy, the highest value should be used), 1.2.2) Involved/uninvolved serum free light chain ratio =100 (values based on the serum Freelite assay. The involved free light chain must be =100 mg/L), 1.2.3) >1 focal lesion detected by MRI (magnetic resonance imaging) studies (each focal lesion must be 5 mm or more in size, According to physician’s opinion, patients can undergo either one of the two standard treatments and procedures, Females of childbearing potential (FBCP) must use an effective contraceptive method for 28 days before the study treatment, during the treatment and for at least 3 months after the last dose of study drugs, Male subjects must use an effective barrier method if sexually active with FCBP during treatment and for at least 6 months after the last dose of study drug, Patients should be ineligible for ASCT, defined as: - = 65 years old; - younger than 65 years but who reject the transplant procedure or with abnormal cardiac, pulmonary, hepatic and renal function defined as: • LVEF (left ventricular ejection fraction) < 40%; • FEV1 (forced expiratory volume-1 second) < 40%; •Bilirubin > 1.5 UNL, AST/ALT >2.5 UNL; • Creatinine clearance < 60 mL/min., Patients with newly diagnosed symptomatic multiple myeloma (NDMM) based on standard IMWG (International Myeloma Working Group) criteria:, 1) Clonal bone marrow plasma cells =10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following CRAB features and myeloma-defining events:, 1.1) Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically, 1.1.1) Hypercalcemia: serum calcium >0.25 mmol/L (>1mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11mg/dL), 1.1.2) Renal insufficiency: creatinine clearance (CLcr)<40 mL per minute (measured or estimated by validated equations) or serum creatinine > 177 µmol/L (>2mg/dL), 1.1.3) Anemia: hemoglobin value of >20g/L below the lower limit of normal, or a hemoglobin value <100g/L, 1.1.4) Bone lesions: one or more osteolytic lesion on skeletal radiography, CT, or PET/CT. If bone marrow has <10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement, 1.2) Any one or more of the following biomarkers of malignancy:

Exclusion Criteria

Hypersensitivity to any active substance or to any of the excipients (lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, boron, mannitol, nitrogen, crospovidone, colloidal anhydrous silica, hypromellose, titanium dioxide, macrogol, talc, sodium starch glycolate, sodium benzoate, propylene glycol, sodium dihydrogen phosphate, hydroxypropyl beta cyclodextrin, sodium saccharin, sodium EDTA, sodium hydroxide, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sorbitol (E420), recombinant human hyaluronidase (rHuPH20)), Administration of prophylactic vaccine from 8 to 2 weeks before starting treatment, Hereditary intolerance to fructose, Pregnant and lactating women, FBCP that do not follow the Pregnancy Prevention Plan requirements, Acute diffuse infiltrative pulmonary and pericardial disease, Acute viral infections (e.g. herpes simplex or ocular herpes simplex, herpes zoster, varicella), Systemic mycotic or bacterial infections, unless specific anti-infectious therapy is ongoing, Peptic ulcer, Psychosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified