Multiple Myeloma MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Revlimid
Product Name: Lenalidomide
Product Code: CC5013
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Co
Sponsors
Wuerzburg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Understand and voluntarily sign an informed consent form. 2. Age =18 and = 65 years at the time of signing the informed consent form 3. Eligible for autologous and allogeneic stem cell Transplantation 4. Must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma (dexamethasone at a cumulative dose of 320 mg; plasmapheresis/dialysis without concomitant chemotherapy, local irradiation of bone lesions; and surgical intervention is accepted as pretreatment) 5. Newly diagnosed multiple myeloma with the diagnostic criteria as follows: • Monoclonal plasma cells in the bone marrow = 10% (histology) and/or biopsy-proven plasmacytoma • Monoclonal protein present in serum and/or urine on immunofixation • Myeloma-related organ dysfunction, at least one of [C] Calcium elevation in the serum (> 11.5 mg/dL or upper limit of normal) [R] Renal insufficiency (creatinine > 2 mg/dL ) [A] Anemia (Hb 10 mg/dl (> 100 mg/l) provided serum FLC ratio is abnormal. 6. Cardiac ejection fraction (LVEF) of at least 50% assessed by 2-d echocardiography within 28 days prior to first cycle of RAD or VRD 7. Corrected DLCO (single breath) of at least 50% of age-matched controls; alternatively pO2 [art.] of at least 70 mmHg 8. Karnofsky performance status of greater or equal to 50% (see Appendix III) 9. Laboratory test results within these ranges: • Absolute neutrophil count = 1.0 x 109/L • Platelet count = 75 x 109/L • Hemoglobin > 8 g/dL • Calculated creatinine clearance (MDRD) = 30 mL/Minute • Total bilirubin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form 2. Pregnant or lactating females 3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk 4. History of myocardial infarction; NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias; concomitant pericarditis or peri- /myocarditis 5. Use of any other experimental drug or therapy within 28 days of baseline. 6. Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment 7. Known intolerance of boron 8. Hypersensitivity to acyclovir or similar anti-viral drug 9. Prior malignancy 10. HIV positive, active hepatitis B, C or D viral infection, known CMV reactivation/active infection, EBV reactivation/active infection or treponema pallidum infection 11. Uncontrolled diabetes mellitus 12. Non-secretory MM 13. Clinically relevant active infection or serious co-morbid medical conditions 14. Cardiac amyloidosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare CR rate to two induction regimens (one novel agent [RAD] vs. two novel agents [VRD]) in newly diagnosed MM patients and to determine PFS following consolidative treatment.;Secondary Objective: To assess long-term efficacy and safety of the treatment regimen. To assess quality of life in terms of frequency and duration of hospitalization as well as toxicity during different means of consolidation . ;Primary end point(s): The primary efficacy endpoint for the induction phase is CR rate at first restaging In the consolidation phase the primary efficacy endpoint for comparison II (response < VGPR after first ASCT) is the PFS rate at 3 years after the first ASCT, calculated from day 1 of ASCT. In comparison I (response = VGPR after first ASCT), PFS will be compared only exploratively in addition to toxicity and quality of life (in terms of frequency and duration of hospital stays). ;Timepoint(s) of evaluation of this end point: first Restaging and 3 years after first ASCT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ORR rate following 3 cycles of induction treatment (VRD vs RAD ) CR and ORR at the end of the whole treatment programme Overall survival Incidence, severity and relationship of SAEs Numbers of hospital stays and hospitalization days within two years from second restaging. ;Timepoint(s) of evaluation of this end point: first Restaging and end of treatment | — |
Countries
Germany
Contacts
Public ContactStudy office
Wuerzburg University Hospital
Outcome results
None listed