A multicenter, single-arm, open-label safety study of lenalidomide plus dexamethasone in previously treated subjects with Multiple Myeloma.

Celgene International Sàrl0 sites1,400 target enrollmentJuly 7, 2006

ConditionsPreviously treated subjects with Multiple Myeloma

DrugsRevlimid

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Previously treated subjects with Multiple Myeloma
Sponsor: Celgene International Sàrl
Enrollment: 1400
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 7, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Celgene International Sàrl

Eligibility Criteria

Inclusion Criteria

•Signed informed consent.
•At least 18 years of age.
•Able to adhere to the study visit schedule and other protocol requirements.
•Relapsed with refractory multiple myeloma
•Measurable levels of myeloma protein in serum (\>\=0\.5 g/dL) or urine (\>\=0\.2 g / 24\-hour urine collection).
•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 to 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.

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.
•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/mm3 (1\.0 x 10^9/L)
•\- Platelet count \<75,000/mm3 (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 umol/L)
•\- Serum SGOT/AST or SGPT/ALT \>3\.0 x upper limit of normal (ULN)
•\- Serum total bilirubin \>2\.0 mg/dL (34 umol/L)