Newly Diagnosed multiple myeloma MedDRA version: 17.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Revlimid
Product Name: Revlimid
Product Code: CC-5013
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Conce
Sponsors
Meletios-Athanasios Dimopoulos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Principal Inclusion Criteria 1-Subjects able to read and understand the Informed Consent Form. 2-Subjects must demonstrate their willingness to participate in the study and comply with its procedures. 3-Subjects who have signed the Informed Consent Form. 4-Newly diagnosed patients with symptomatic MM (Multiple Myeloma) according to the criteria of IMWG (International Myeloma Working Group). 5-Subjects eligible for autologous stem cell transplantation (?SCT). 6-Age 18-70 years, of either sex. 7-?arnofsky performance status = 60. 8-Platelet count = 100x109/L. 9-Neutrophil count = 1.5x109/L. 10-Serum ALT and AST = 3-fold of upper normal limit. 11-Serum bilirubin = 2-fold of upper normal limit. 12-Creatinine clearance =60 ml/min. 13-Expected survival = 6 months as per investigator’s clinical judgment. 14-Subjects able to tolerate aspirin, low molecular weight heparin or coumarinic agents as prophylactic anticoagulation. 15-Female subject of childbearing potential must have a negative serum pregnancy test (hCG) at Screening and if sexually active must be using a medically acceptable, highly effective, adequate form of birth control (ie, failure rate =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1-Women who are pregnant or breastfeeding or who intend to become pregnant during the trial. 2-Suspected or known hypersensitivity to any of the study treatment components. 3-Ongoing severe infection requiring intravenous antibiotic treatment. 4-Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in- situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years. Concurrent prostate cancer for which the patient is receiving therapy will not be considered an exclusion if the PSA has been stable for three years. 5-Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia. 6-Myocardial infarction within 6 months before enrolment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities. 7-Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary, hepatic and renal diseases unless renal insufficiency is considered to be secondary to multiple myeloma. 8-Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 9-Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she will participate in the study or confounds the ability to interpret data from the study. 10-Subjects with any clinical condition that would affect study’s outcome according to physician’s discretion. 11-Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives: Secondary endpoints of this study are the following: • Assessment of the efficacy of RAD regimen, as measured by disease free survival, time to disease progression and time to next therapy • Assessment of the safety of RAD regimen (lenalidomide, adriamycin, low dose dexamethasone) in newly diagnosed patients with symptomatic MM eligible for ASCT. ;Primary end point(s): Primary end point: The primary endpoint of this study is the assessment of the overall response rate of study population to RAD regimen (including stringent complete response, complete response, very good partial response, partial response and stable disease) according to the uniform criteria of IMWG (?nternational Myeloma Working Group) regarding the response to multiple myeloma therapy. ;Timepoint(s) of evaluation of this end point: The overall response rate, i.e. the total percentage of patients with progression-free survival (including sCR, CR, VGPR, PR and SD) will be estimated at Day 1 of each treatment cycle.;Main Objective: Primary Objective: The primary objective of this study is to evaluate the response to lenalidomide in combination with adriamycin and low dose of dexamethasone (RAD regiment) in newly diagnosed patients with symptomatic MM eligible for high dose therapy and ASCT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Progression-free survival (PFS), which will be calculated using Kaplan-Meier statistical method. 2. Time to progression (TTP), which will also be calculated by Kaplan-Meier statistical method.The time to disease progression is defined as the time from the initiation of the administration of RAD regimen, Day 1 – Cycle 1, to time of progressive disease. For patients who died without having previously recorded the date of disease progression, the date of last assessment will be considered as the date of progressive disease. 3. Time to Next Therapy (TtNT), which will be also measured with the use of Kaplan-Meier method. The time to next therapy is defined as the time from the initiation of RAD regimen administration, Day 1 – Cycle 1, to time of commencement of next anticancer therapeutic regimen for multiple myeloma. 4. Safety and toxicity profile of the investigational RAD regimen. Adverse events will be assessed at each visit and graded according to the National Cancer Institute Common Toxicity Criteria (version 2.0). ;Timepoint(s) of evaluation of this end point: A. PFS Serum ?-component >0.5 g/d) Urine ?-component > 200 mg/24h) In patients without measurable serum and urine ?-protein levels >10 mg/dl Bone marrow plasma cell percentage >10% Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcemia (corrected serum calcium >11.5 mg/dl B. TTP From the initiation of the administration of RAD regimen, Day 1 – Cycle 1, to time of progressive disease. For patients who died the date of last assessment will be considered as the date of progressive disease. C. TtNT From the initiation of RAD regimen administration, Day 1 – Cycle 1, to time of commencement of next anticancer therapeutic regimen. | — |
Countries
Greece
Contacts
Public ContactMeletios-Athanasios Dimopoulos
Meletios-Athanasios Dimopoulos
Outcome results
None listed