Allogeneic transplantation for patients with multiple myeloma MedDRA version: 14.1 Level: LLT Classification code 10059041 Term: Allogeneic peripheral haematopoietic stem cell transplant System Organ Class: 100000004865 MedDRA version: 14.1 Level: PT Classification code 10018651 Term: Graft versus host disease System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: Velcade
Product Name: bortezomib
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BORTEZOMIB
CAS Number: 179324-69-7
Concentration unit: mg/m2 milligram(s)/squar
Sponsors
European Myeloma Network
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for the phase II trial: o High-risk multiple myeloma patients at first relapse / second complete remission candidates to receive an allogeneic transplantation o Age: ³ 18 =65 years) F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Patient who is a known carrier of the human immunodeficiency virus (HIV), hepatitis B virus surface antigen or active infection by the hepatitis C virus (those in which the hepatitis C virus RNA can be detected). - Patients who have experienced a myocardial infarction within 6 months prior to entry in the clinical trial or are in New York Heart Association (NYHA) functional class III or IV, heart failure, uncontrolled angina, uncontrolled ventricular arrhythmia or acute ischemia detected in the ECG, or conduction system abnormalities. - Patients who are currently in another clinical trial or receiving any investigational agent - Prior history of other malignant diseases other than myeloma (except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) unless the patient is disease-free longer than 5 years. - Hypertension or poorly-controlled diabetes mellitus or any other serious organic disease involving an excessive risk to the patient or any psychiatric disorder that interferes with the understanding of the informed consent o Prior severe comorbidity such as: Cirhosis · Peripheral neuropathy ³ Grade 2 14 days prior to inclusion · Psychiatric disease · Hypersensitivity to Bz, Boric acid manitol. · Patients unable to use appropriate contraceptive methods · Patients who have received an investigational drug 30 days prior to inclusion · Patients with pericardial disease · Patients with acute diffuse infiltrative pulmonary · Patients not willing to comply with the Lenalidomide Pregnancy Prevention Risk Management Plan · Patients not willing to receive thromboprophylaxis during the consolidation phase will not be eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For the phase II trial on patients with multiple myeloma: Evaluate the toxicity of the maintenance with bortezomib and lenalidomide;Secondary Objective: For the phase II trial on patients with multiple myeloma: · Analyze the response and relapse rate of this approach · Evaluate the toxicity of the procedure in terms of acute and chronic GVHD and mortality · Evaluate the toxicity of the procedure · Evaluate the efficacy of VRD in terms of improvement of disease response · Evaluate the efficacy of the procedure in terms of event free and overall survival · Analyze the prognostic value and efficacy of imaging studies using PET and local radiotherapy in involved fields prior to or after (> 100 days) conditioning;Primary end point(s): For the phase I trial: Safety, assessed as toxicity and incidence of GVHD, of the combination sirolimus plus Bz for GVHD prophylaxis in patients with hematologic malignancies undergoing allogeneic transplantation For the phase II trial: Safety and efficacy of an optimized strategy of allogeneic transplantation among patients with multiple myeloma;Timepoint(s) of evaluation of this end point: Safety evaluation will be performed every 5 patients in order to analyze the tolerability and feasibility of the approach. Once confirmed we will also analyze the impact of this approach on the efficacy of the procedure in terms of response and relapse rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Response and relapse rate - Toxicity - Improvement of disease response - Event free and overall survival - Prognostic value and efficacy of imaging studies using PET and local radiotherapy in involved fields prior to or after conditioning;Timepoint(s) of evaluation of this end point: None | — |
Countries
Sweden
Contacts
Public ContactJosé Antonio Pérez Simón
European Myeloma Network
Outcome results
None listed