Status:
COMPLETED
A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma
Lead Sponsor:
Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To evaluate the safety and efficacy of lenalidomide with dexamethasone in Japanese patients with previously treated multiple myeloma.
Eligibility Criteria
Inclusion
- Must understand and voluntarily sign the informed consent form
- Age ≥ 20 years at the time of signing the informed consent form
- Subjects with previously treated multiple myeloma defined as follows:
- Subjects must have received at least 1 prior anti-myeloma drug treatment regimen; and
- Considered to have progression of disease (PD) that occurred either during or following the completion of the last anti-myeloma treatment regimen utilized prior to enrollment into this study
- Measurable levels of M-protein in serum (greater than or equal to 0.5 g/dL \[5g/L\]) or urine (greater than or equal to 0.2 g excreted in a 24-hour collection sample)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Must be able to adhere to the study visit schedule and other protocol requirements
- Females of childbearing potential (FCBP) must agree to use one or more of the following forms of contraception or abstain from heterosexual contact completely and have the male partners use a condom on the occasion of heterosexual contact in the following periods below:
- For at least 28 days before starting study drug (in particular, the subject must abstain from heterosexual contact for 2 weeks prior to prescribing lenalidomide).
- During the treatment phase (including the dose withholding period) For at least 28 days after the discontinuation/completion of the study drug (Methods of contraception)
- Birth control pills
- Intrauterine device (IUD)
- Bilateral tubal ligation (FCBP must be referred to a health care provider who is familiar with contraceptive methods, if needed).
- Male subject must agree to use a condom during sexual contact with female irrespective of pregnancy potential
- Subjects must agree that study drug must be immediately discontinued, if pregnancy or a positive pregnancy test does occur in a female study subject or the partner of a male study subject during study participation
Exclusion
- Pregnant or lactating females
- Subjects with a history of acute myocardial infarction within the past 6 months before starting the study drugs
- Subjects with any history or concurrent conditions of deep vein thrombosis or pulmonary embolus within the past 3 years before starting study drugs
- Subjects with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases
- Subjects with non-controlled diabetes, hypertension, digestive ulcer or glaucoma
- Subjects with posterior subcapsular cataracts
- Subjects with peripheral neuropathy of ≥Grade 2
- Subjects with any history or concurrent conditions which the Principal Investigator / subinvestigators consider inappropriate for participation in this study, and subjects with a serious disease or a mental disease, which is considered to become more risky if the subjects participate in this study.
- Subjects with a history of desquamative (blistering) rash while taking thalidomide
- Subjects with a history of using lenalidomide
- Subjects who have used thalidomide within 28 days before starting the study drugs
- Subjects with a history of hypersensitivity to dexamethasone
- Subjects who discontinued treatment due to grade 3 or 4 toxicity from high dose dexamethasone
- Subjects with a surgical wound after a visceral surgery performed recently
- Subjects who have undergone radiation therapy within 14 days before starting the study drugs
- Subjects who have used a chemotherapeutic agent, an immunomodulating agent or a study drug (a drug not commercially available) intended for the treatment of multiple myeloma (MM) within 28 days before starting the study drug
- Subjects with any history or concurrent conditions of malignancies, other than MM, unless the subject has been free of the disease for 3 years:
- Basal cell carcinoma of the skin,
- Squamous cell carcinoma of the skin,
- Carcinoma in situ of the cervix,
- Carcinoma in situ of the breast,
- Incidental histologic finding of prostate cancer Tumor, Lymph Nodes, Metastasis (TNM) stage of T1a or T1b)
- Known human immunodeficiency virus (HIV) infection or HIV-1 positivity
- Subjects who have been diagnosed as an hepatitis b virus (HBV) carrier
- Subjects who are applicable to any of the following abnormal laboratory findings:
- Absolute neutrophil count : \< 1,000 /μL (1.0×10\^9 /L)
- Platelet count: \<75,000 /μL (75×10\^9 /L)
- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT): \> 3.0 times the upper limit of the standard range
- Creatinine clearance: \< 30 mL/min
Key Trial Info
Start Date :
April 28 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00928486
Start Date
April 28 2009
End Date
September 10 2010
Last Update
November 20 2019
Active Locations (8)
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1
Nagoya Medical Center
Nagoya, Aichi-ken, Japan, 460-0001
2
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 467-8602
3
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan, 814-0180
4
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan, 602-8566