Clinical trial NCT00928486: A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma
Official title: A Safety Confirmation Study On Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
timeFrame: Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
Secondary outcomes:
measure: Myeloma Response Rate
timeFrame: From the time of the first dose of study drug to study completion; median duration on study was 42.1 weeks
measure: Kaplan-Meier Estimates of Duration of Response (DoR)
timeFrame: From the time of the first dose of study drug to study completion; the median duration on study was 42.1 weeks
Other outcomes:
Locations:
city: Nagoya-city
country: Japan
facility: Nagoya Medical Center
state: Aichi
city: Nagoya-city
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Fukuoka-city
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka
city: Kyoto-city
country: Japan
facility: Kyoto Prefectural University of Medicine
state: Kyoto
city: Niigata-city
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Osaka-city
country: Japan
facility: Osaka Red Cross Hospital
state: Osaka
city: Tokushima-city
country: Japan
facility: Tokushima University
state: Tokushima
city: Tokyo
country: Japan
facility: Keio University Hospital
Study officials:
affiliation: Celgene KK
name: Masaaki Takatoku, MD
role: STUDY_DIRECTOR
References: