Multiple Myeloma MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: DARZALEX - 20 MG/ML- CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO)- 20 ML- 1 FLACONCINO
Product Name: Darzalex
Product Code: [JNJ-54767414]
Pharmaceutical For
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18-85 years at the time of signing the informed consent form Able to adhere to the study visit schedule and other protocol requirements >VGPR/MRD-positive by NGF measured by 2-tubes optimized 8-color antibody panel, (OneFlow PCST e PCD BD Biosciences) At least 12 weeks from any therapy for myeloma Eastern Cooperative Oncology Group performance status score of 0, 1, or 2 Laboratory values and electrocardiogram within protocol-defined parameters at screening All previous MM therapy, including radiation, cytostatic therapy and surgery, must have been terminated at least 4 weeks prior to treatment in this study, without corticosteroid therapy. Laboratory test results within these ranges: Absolute neutrophil count greater / equal 1.0 x 109/L Platelet count greater / equal 75 x 109/L Creatinine clearance > 30 ml/h) Total bilirubin less than / equal 1.5 mg/Dl Aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT; SGPT) less than / equal 2 x ULN Disease free of prior malignancies for greater / equal 5 years with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast Fertile patients must use effective contraception during and for 6 months after study treatment Patients must sign on an Informed Consent Form No study treatment or any other procedure within the framework of the trial (except for screening) will be performed in any patient prior to receipt of written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: Received daratumumab or other anti-CD38 therapies previously Nonsecretory multiple myeloma Previously received an allogenic stem cell transplant or has received an autologous stem cell transplantation within 12 weeks Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years Absence of the Informed Consent Form signed by the patient Pregnant or breast feeding females Use of any other experimental drug or therapy within 28 days of baseline. Known hypersensitivity to the study drugs Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C. Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of the study is Daratumumab efficacy: in particular capacity to determine increase of response by MRD negativity, detected by NGF assessment on bone marrow specimens;Secondary Objective: Rate of acute and late toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria.;Primary end point(s): MRD negativity will be measured at time 2 , 6, 12,18,24 months by Flow cytometry on bone marrow aspirate. MRD negativity will be defined as absence of monoclonal plasma cells with a sensitivity of 1x105 cells analyzed by Euro flow protocols.;Timepoint(s) of evaluation of this end point: 2 , 6, 12,18,24 mounths | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Complete remission rate (CR), Duration of response (DoR) and progression free survival (PFS).;Timepoint(s) of evaluation of this end point: 2,6,12,18 e 24 mounths | — |
Countries
Italy
Contacts
Public ContactUOC Ematologia
Azienda Ospedaliera Universitaria Senese
Outcome results
None listed