A multicentre, single-arm, open-label expanded access study of lenalidomide plus dexamethasone in previously treated subjects with relapsed/refractory multiple myeloma

• Conditions: Previously treated subjects with relapsed/refractory multiple myeloma; MedDRA version: 8.1Level: PTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2006-002517-12-IE
• Lead Sponsor: Celgene International Sarl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• Signed informed consent.
• At least 18 years of age.
• Able to adhere to the study visit schedule and other protocol requirements.
• Relapsed/refractory multiple myeloma.
• Measurable levels of myeloma protein in serum (=0.5 g/dL) or urine (=0.2 g / 24-hour collection sample).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 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 [injections, or implants], tubal ligation, partner’s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). Combined oral contraceptive pills are not recommended because they carry an increased risk of venous thromboembolism. If a patient is currently using combined oral contraception switching to another adequate method of contraception should be considered. The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception. If alternative methods are unacceptable, thromboprophylaxis should be considered while continuing combined oral contraception. The patient should be adequately informed about the risks of venous thromboembolism. 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. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug. The subject may not receive study drug until the Investigator has verified that the results of these pregnancy tests are negative.
• Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure.
• 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.
• Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure.
• Must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from the study.
During study participation and for 28 days following discontinuation from the study:

All Subjects:
• No more than a 28-day supply of study drug will be dispensed at a time.
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. If menstrual cycles are irregular, the pregnancy testing must occur we

Exclusion Criteria

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or lactating females.
• Prior therapy with lenalidomide
• 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.
• Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)
- Platelet count <75,000/mm^3 (75 x 10^9/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.
- Platelet count <30,000/mm3 (30x10^9/L) for subjects in whom >=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.
• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To provide lenalidomide to subjects with a high likelihood of benefit;Secondary Objective: • To obtain additional safety data.<br>• To assess the impact on quality of life (QoL);Primary end point(s): • Safety (type, frequency, severity, and relationship of adverse events to study drug).<br>• QoL assessment (European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Cancer [EORTC QLQ C-30] and QoL Questionnaire for Patients with Multiple Myeloma [QLQ MY-24] Module)