Multiple Myeloma MedDRA version: 16.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Revlimid
Product Name: Lenalidomide
Product Code: CC 5013
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lenalidomide
Current Sponsor code: Lenalidomide
Other descriptive name: Re
Sponsors
Universitaetsklinikum Wuerzburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Inclusion Criteria (for RAD) 1.Understand and voluntarily sign an informed consent form. 2.Age = 18 and 11.5 mg/dL or upper limit of normal) - [R] Renal insufficiency (creatinine > 2 mg/dL) - [A] Anemia (Hb =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. Progressive disease (PD) to any initial treatment, such as dexamethasone, dex-anthracycline combinations or melphalan/prednisone. Those patients are considered to have refractory disease, the treatment of which is not an endpoint of this protocol. 3. Pregnant or lactating females. 4. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 5. Use of any other experimental drug or experimental therapy within 28 days of baseline and for duration of the entire study. 6. Neuropathy of <= grade 2 severity 7. Known hypersensitivity to thalidomide. 8. The development of erythema nodosum; if characterized by a desquamating rash while taking thalidomide or similar drugs. 9. Any prior use of lenalidomide. 10. Positive for HIV or infectious hepatitis, type A, B or C or treponema pallidum after serologic testing 11. History of myocardial infarction (both STEMI and non-STEMI). 12. Concomitant myocarditis or perimyocarditis. Exclusion criterion for second cycle of high-dose melphalan 13.The second cycle of high-dose melphalan must only be initiated if in addition to the planned graft a “back up” of at least 2 x 106 CD34+ cells of the patient be present that may be used in case of graft failure. Exclusion criteria for allogeneic stem cell transplantation 14. Serum creatinine despite induction therapy = 2.0 mg/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine efficacy of the novel induction regimen (combination of lenalidomide, adriamycin, and dexamethasone; RAD) followed by a risk-defined transplant strategy and subsequent lenalidomide maintenance in patients with symptomatic multiple myeloma;Secondary Objective: To assess long-term efficacy and safety of the treatment regimen;Primary end point(s): Response rate (sCR, CR, or VGPR) at the start of scheduled lenalidomide maintenance Secondary end point(s) • Other efficacy parameters according to the international uniform response criteria, including objective response (sCR, CR, VGPR, or PR), progression-free (PFS) and overall survival (OS), and time to next anti-myeloma therapy •Incidence of adverse events taking into account type, severity, and relationship to study treatment | — |
Countries
Germany
Outcome results
None listed