Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma
NCT ID: NCT00555100
Last Updated: 2019-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2007-07-01
2010-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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lenalidomide
10mg-25mg PO/day,day1-day21 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
dexamethasone
40mg PO/day, day1-4,9-12,17-20 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
Eligibility Criteria
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Inclusion Criteria
* Measurable levels of m-protein in serum \>= 0.5 g/dL \[5g/L\]) or urine (\>= 0.2 g excreted in a 24-hour collection sample)
* ECOG performance status of 0 - 2
* Willing to follow pregnancy precautions
Exclusion Criteria
* Patients with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases
* Patients with non-controlled diabetes, hypertension, digestive ulcer or glaucoma
* Patients with posterior subcapsular cataracts
* Patients with mental illness
* Patients with past histories or complications which make the Investigator or other staff member deem them inappropriate for this study
* Pregnant or lactating females
* Grade 2 or worse neuropathy
* Any of the following laboratory abnormalities:
Absolute neutrophil count (ANC) \< 1,000cells/mL Platelet count \< 75,000/mL Serum creatinine \> 2.5 mg/dL Serum SGOT/AST or SGPT/ALT \> 3.0 x upper limit of normal (ULN)
* Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for \>= 3 years. - Patients who received radiation therapy within 14 days of the start of study drug
* Patients with scars from a recent viscus operation
* Patients with history of a desquamating (blistering) rash while taking thalidomide
* Patients with prior use of lenalidomide
* Patients with known HIV positivity.
* Patients who used cytotoxic chemotherapeutic agents, immunomodulating agents, or other experimental agents (agents that are not commercially available) intended for the treatment of MM within 28 days of the start of lenalidomide therapy.
* Patients with known history of hypersensitivity to dexamethasone.
20 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Masaaki Takatoku, M.D.
Role: STUDY_DIRECTOR
Celgene K.K.
Locations
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Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Keio University Hospital
Tokyo, , Japan
Countries
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References
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Iida S, Chou T, Okamoto S, Nagai H, Hatake K, Murakami H, Takagi T, Shimizu K, Lau H, Takeshita K, Takatoku M, Hotta T. Lenalidomide plus dexamethasone treatment in Japanese patients with relapsed/refractory multiple myeloma. Int J Hematol. 2010 Jul;92(1):118-26. doi: 10.1007/s12185-010-0624-7. Epub 2010 Jun 18.
Other Identifiers
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CC-5013-MM-017
Identifier Type: -
Identifier Source: org_study_id
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