A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma

NCT ID: NCT00928486

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-28
• Study Completion Date: 2010-09-10

Brief Summary

To evaluate the safety and efficacy of lenalidomide with dexamethasone in Japanese patients with previously treated multiple myeloma.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenalidomide and Dexamethasone

Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

Lenalidomide 25mg PO for (days 1 - 21) of a 28-day cycle

Dexamethasone

Intervention Type: DRUG

Dexamethasone 40 mg by mouth (PO) daily (QD) on days 1-4, 9-12 and 17-20 of each 28 day cycle

Interventions

Lenalidomide

Lenalidomide 25mg PO for (days 1 - 21) of a 28-day cycle

Intervention Type: DRUG

Dexamethasone

Dexamethasone 40 mg by mouth (PO) daily (QD) on days 1-4, 9-12 and 17-20 of each 28 day cycle

Intervention Type: DRUG

Other Intervention Names

CC-5013; Revlimid; Decadron

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masaaki Takatoku, MD

Role: STUDY_DIRECTOR

Celgene KK

Locations

Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, Japan

Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Osaka Red Cross Hospital

Osaka, Osaka, Japan

Tokushima University

Tokushima, Tokushima, Japan

Keio University Hospital

Tokyo, , Japan

Countries

Japan

Other Identifiers

CC-5013-MM-022

Identifier Type: -

Identifier Source: org_study_id