Patients with refractory or advanced Multiple Myeloma. MedDRA version: 9.1 Level: LLT Classification code 10051381 Term: Myeloma recurrence
Conditions
Interventions
Trade Name: Thalidomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Thalidomide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form
Sponsors
FONDAZIONE NEOPLASIE SANGUE ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients must have a diagnosis of active MM according to the International Myeloma Working Group criteria (IMWG, 2003), and be deemed by the investigator as requiring treatment. -Patient has measurable disease -Patients must have received at least one prior line of therapy and their disease has relapsed -Patients did not show any sign of progressive disease (PD) during previous melphalan or thalidomide therapy, any previous short remission induced by MP =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Prior exposure to a HDAC inhibitor compound used in the treatment of MM. -Patients with non-secretory MM. -Patients who have received allogeneic stem cell transplantation < 12 months prior to entering the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine whether the combination LB-MPT (with escalating dose of LB589) is safe and effective in advanced/refractory MM patients.;Secondary Objective: Determine the long-term efficacy of the combination LB-MPT.;Primary end point(s): The safety profile will be assessed by showing: 1. - any grade 3 non-hematologic toxicity 2. - grade 4 neutropenia ≥ a week, or any grade 4 hematologic toxicity except neutropenia The efficacy will be assessed by showing a significant PR rate, based on the International Uniform Response Criteria for multiple myeloma by the International Myeloma Working Group (Durie B et.al., 2006). | — |
Countries
Italy
Outcome results
None listed