Relapsed or Refractory Multiple Myeloma MedDRA version: 8.1 Level: PT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: REVLIMID
Product Name: Lenalidomide
Product Code: CC-5013
Pharmaceutical Form: Capsule, hard
CAS Number: 191732-72-6
Current Sponsor code: Lenalidomide
Concentration unit: mg milligram(s)
Sponsors
Celgene International Sàrl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study: • Must understand and voluntarily sign an informed consent form. • Must be = 18 years of age at the time of signing the informed consent form. • Must be able to adhere to the study visit schedule and other protocol requirements. • Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment. • Subjects may have been previously treated with thalidomide and/or radiation therapy. In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given concurrently with study therapy, provided that all other eligibility criteria are satisfied. • Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the first dose of study drug with the exception of radiation therapy initiated prior to or at baseline (Day 1). • Measurable levels of myeloma paraprotein in serum (=0.5 g/dL) or urine (= 0.2 g excreted in a 24-hour collection sample). • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. • Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner’s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed. Before starting study drug: Female Subjects: • FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. • Must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from the study. Male Subjects: • Must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy. • Must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from the study. Female Subjects: • FCBP with regular cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following discontinuation from the study. • Counseling about pregnancy precautions and th
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude a subject from study enrolment: • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. • Pregnant or lactating females. • 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, including severe uncontrolled diabetes mellitus. • Any of the following laboratory abnormalities: - Absolute neutrophil count (ANC) 50% of bone marrow nucleated cells are plasma cells. - Serum creatinine >2.5 mg/dL (221 µmol/L) - Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN) - Serum total bilirubin >2.0 mg/dL (34 µmol/L) • Prior history of malignancies other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for =1 year. • Prior history of stroke and / or thromboembolic event • Known hypersensitivity to thalidomide or dexamethasone. • Prior history of uncontrollable side effects to dexamethasone therapy. • The development of a desquamating rash while taking thalidomide. • Neuropathy =Grade 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the time to progression (TTP) of previously treated subjects with multiple myeloma receiving lenalidomide;Secondary Objective: • To obtain additional safety data • To assess the time to partial response • To assess the response rate ;Primary end point(s): Time to disease progression | — |
Countries
Germany
Outcome results
None listed