Multiple Myeloma patients candidate to high-dose therapy MedDRA version: 14.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Diagnosis of Symptomatic Multiple Myeloma based on IMWG 2003 criteria (all three required): • Monoclonal protein present in the serum and/or urine • Monoclonal plasma cells in the bone marrow =10% and/or presence of a biopsy-proven plasmacytoma • Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2 mg/dl) [A] Anemia (hemoglobin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Diagnosis of smoldering myeloma or MGUS or Waldenstrom’s disease or other conditions in which IgM M-protein is presenting the absence of a clonal plasma cell infiltration with lytic bone lesions. • Diagnosis of plasma cell leukaemia, • Prior or current systemic therapy for multiple myeloma including steroids before randomisation • Prior treatment with HDAC as treatment for cancer except for Valproic Acid used for non-cancer indications such as migraine prevention and seizure disorder. • Radiotherapy within 30 days before entry and with more than 25% of bone marrow reserve irradiated • Plasmapheresis within 30 days before entry • Major surgery within 30 days before entry • Patient has a history of a gastrointestinal surgery or other procedures that might, in the opinion of the Investigator, interfere with the absorption or swallowing of the study drug(s) • History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances • Uncontrolled diabetes • Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 4, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis • Patient has pre-existing NCI CTC Grade 1 neuropathy with pain or =Grade 2 neuropathy • Patient is a regular user or had a recent history (within the last year) of any illicit drugs, or substance abuse • Serious medical or psychiatric illness likely to interfere with participation in the clinical study • Receipt of experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study • Other malignancy within the past 5 years. Exceptions for the following if treated and not active: basal cell or non metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or International Federation of Gynaecology and Obstetrics stage 1 carcinoma of the cervix • Pregnant or breastfeeding • Women of childbearing potential (WOCBP) not willing to use a double method of contraception during the study and 3 months after the study evaluation completion treatment, of which one must be a barrier method. • Patient is a male not willing to use a barrier method of contraception during the study and for 3 months after the study evaluation completion treatment. • Known hypersensitivity allergy or inability to tolerate any of the agent employed • Patient receiving treatment with any medications which have a relative risk of prolonging the QT interval or inducing Torsades de points.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. to determine if Panobinostat has an impact on peripheral blood stem cell mobilization (PBSC); 2. to evaluate if this high-dose protocol improves the outcome increasing the overall response rate (ORR), improving time to response (TTR) and prolonging progression free survival (PFS), overall survival (OS), duration of response (DOR), time to progression (TTP), time to next treatment (TNT), treatment free interval (TFI). 3. to determine the feasibility and toxicity of the protocol.;Primary end point(s): Percentage of complete response (CR).;Timepoint(s) of evaluation of this end point: Not applicable.;Main Objective: To evaluate if the combination of Panobinostat, Bortezomib and high-dose Dexamethasone as induction therapy can increase the complete response (CR) rate in subjects with previously untreated multiple myeloma who are candidates to autologous stem cell transplantation (ASCT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ORR: comprising CR, near CR, VGPR (Very Good Partial Reponse) and partial response (PR); TTR, PFS, OS, DOR, TTP, TNT, TFI. Secondary safety endpoints: AEs, ECG parameters, laboratory parameters;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Italy
Contacts
Public ContactStruttura di Ematologia
Fondazione IRCCS Policlinico San Matteo
Outcome results
None listed