A randomized trial of maintenance treatment between Lenalidomide and Placebo administred after a combination of Melphalan, Prednisone and Bortezomib as 1st intention in subjects diagnosed with multiple myeloma.
- Conditions
- ewly diagnosed multiple myeloma (NDMM)MedDRA version: 17.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-001729-26-FR
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 351
Related to initial diagnosis and prior MPV induction therapy
1. Previously untreated and symptomatic multiple myeloma.
2. All 3 criteria (Durie, 2003) and at least one of the CRAB criteria must be met
(Appendix K).
3. Measurable disease by 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. (Please refer to the Velcade European Public Assessment Report (EPAR), Version 07 Jun 2013 for more information regarding the approved MPV regimens.)
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 cytogenetic (17 p deletion, and 4;14 translocation), ß-2 microglobulin and serum albumin (ISS Stage) results from their initial diagnosis available at the time of screening (Appendix L).
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 A-E).
b. Agree to abstain from donating blood while taking IP therapy and following discontinuation of IP therapy (Appendices A-E).
c. Agree not to share study medication with another person (Appendices A-E).
d. All FCBP and male subjects must be counseled about pregnancy precautions and risks of fetal exposure (Appendices A-E).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 334
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. Patients 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. Pregnant or lactating females.
6. Any of the following laboratory abnormalities:
-Absolute neutrophil count (ANC) < 1,000/?L (1.0 x 109/L)
-Untransfused platelet count < 50,000 cells/?L (50 x 109/L)
-Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
-Serum bilirubin levels > 1.5 x ULN
7. Renal insufficiency (creatinine clearance [CrCl] < 30 mL/min by Cockroft-Gault method) or actual CrCl result.
8. Prior history of malignancies including skin cancer, other than multiple myeloma.
9. Prior history of deep venous thrombosis (DVT) or pulmonary embolus (PE) within 3 years of randomization.
10. Subjects who are unable or unwilling to undergo anti-thrombotic therapy.
11. Peripheral neuropathy of > Grade 2 severity according to the NCI CTCAE Version 4.0.
12. Known HIV positivity or active infectious hepatitis, type A, B, or C.
13. Primary amyloidosis (immunoglobulin light chain) and myeloma complicated by amyloidosis.
14. Prior allogeneic or autologous stem cell transplantation.
15. 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
16. Any condition that confounds the ability to interpret data from the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method