Newly diagnosed multiple myeloma (NDMM) MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Revlimid 2.5 mg, Hard capsules
Product Name: Lenalidomide
Product Code: CC-5013
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Current Sponsor
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Related to initial diagnosis and prior MPV induction therapy 1. Previously untreated and symptomatic multiple myeloma. 2. All 3 criteria (Durie, 2003) including and at least one of the CRAB criteria must be met (Appendix K). 3. Measurable disease by serum and / or urine protein electrophoresis analyses. 4. All subjects must be treated with a minimum of 6 and a maximum of 9 cycles of MPV induction regimen, and must have achieved at least PR as best overall response and maintained at MPV discontinuation. If a subject achieves CR prior to at least 6 cycles, the subject will be eligible, but a minimum of 6 cycles must be administered otherwise. For the MPV approved regimen, please refer to the Velcade® European Public Assessment Report (EPAR), version 07 Jun 2013. Per investigator decision, the following modifications to the EPAR dosing regimen can be accepted: a. Velcade® administration adaptation as long as a minimum of 24 injections and a maximum of 52 injections is given, b. Prednisone can be replaced by Dexamethasone, c. Melphalan can be administered intravenously if dose-intensity is similar to oral Melphalan. 5. Subjects must not have received any prior anti-myeloma chemotherapy or any investigational agent except 6-9 cycles of induction therapy with MPV. 6.Subjects must have ß-2 microglobulin and serum albumin (ISS Stage) (Appendix L) and cytogenetic (17 p deletion, and 4;14 translocation abnormalities [Appendix O]), results from their initial diagnosis available at the time of screening. However, if the cytogenetic test at initial diagnosis was not performed or the results were inconclusive, the test should be performed at any time before study entry. Any conclusive results from initial diagnosis will be used (Appendix O). Related to the subject 7. Must understand and voluntarily sign the informed consent document prior to the conduct of any study related assessments/procedures, 8. Age = 65 years: if < 65 years of age, the subject must be non eligible for stem cell transplantation, 9. Eastern Cooperative Oncology Group (ECOG) (Appendix G) performance status score = 2, 10. Able to adhere to the study visit schedules and other protocol requirements, 11. Females of Childbearing Potential * (FCBP) must: a. Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence2 from heterosexual contact (Appendices A-E). b. Either commit to true abstinence † from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy (Appendices A-E). 12. Male Subjects must: a. Practice true abstinence † or agree to use a condom during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions and for at least 28 days following IP discontinuation, even if he has undergone a successful vasectomy (Appendices A-E). b. Agree to not donate semen during IP therapy and for 28 days after end of study therapy (Appendices A-E). 13. All subjects must: a. Have an understanding that the study medication could have a potential teratogenic risk (Appendices
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude the subject from the study enrollment: 1. Previous treatment with anti-myeloma therapy other than the required 6-9 cycles of MPV induction therapy (does not include local radiotherapy, bisphosphonates, or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]). 2. Subjects who didn’t achieve PR or better after getting at least 6 cycles of MPV (see the Velcade EPAR, Version 07 Jun 2013) and at the end of MPV whatever the overall response are not eligible. 3. Prior therapy with immunomodulating or immunosuppressive agents, or epigenetic or DNA modulating agents. Subjects who received investigational agents are also excluded. 4. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 5. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 6. Pregnant or lactating females. 7. Any of the following laboratory abnormalities: -Absolute neutrophil count (ANC) 3.0 x upper limit of normal (ULN) -Serum bilirubin levels > 1.5 x ULN 8. Renal insufficiency (creatinine clearance [CrCl] Grade 2 severity according to the NCI CTCAE Version 4.0. 13. Known Human Immunodeficiency Virus (HIV) positivity or known active infectious hepatitis, type A, B, or C. 14. Primary amyloidosis (immunoglobulin light chain) and myeloma complicated by amyloidosis. 15. Prior allogeneic or autologous stem cell transplantation. 16. Significant active cardiac disease within the previous 6 months including: -New York Heart Association class II-IV congestive heart failure -Unstable angina or angina requiring surgical or medical intervention -Myocardial infarction 17. Any condition that confounds the ability to interpret data from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the overall survival (OS) of maintenance therapy with lenalidomide versus placebo after Melphalan Prednisone Velcade® (MPV) induction therapy in subjects with NDMM who are either = 65 years of age or are not otherwise candidates for stem cell transplantation (SCT).;Secondary Objective: -To compare the safety of lenalidomide alone versus placebo given until documented PD;Primary end point(s): OS defined as the time from the date of randomization to the date of death due to any cause.;Timepoint(s) of evaluation of this end point: OS defined as the time from the date of randomization to the date of death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Safety (AEs [type, frequency, and severity of AEs, and relationship of AEs to investigational product(IP)], SAEs, laboratory abnormalities, hospitalizations, and SPMs) ;Timepoint(s) of evaluation of this end point: -Safety (AEs [type, frequency, and severity of AEs, and relationship of AEs to investigational product(IP)], SAEs, laboratory abnormalities, hospitalizations, and SPMs) | — |
Countries
Belgium, France, Greece, Italy, Spain
Contacts
Public ContactClinicalTrialDisclosure
Celgene Corporation
Outcome results
None listed