Clinical trial NCT00555100: Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma
Official title: A Multicenter, Phase I Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2007-11-07
Enrollment: 15
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: CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in Japanese subjects with previously treated MM. The study will consist of two cohorts: 1) Monotherapy "Maximum Tolerated Dose (MTD) Determination" Cohort; and 2) "Combination Treatment" Cohort.


Eligibility criteria: Inclusion Criteria:

* Subjects with previously treated multiple myeloma
* 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 acute an myocardial infarction (MI) within the past 6 months, or patients with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 3 years
* 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.

Primary outcomes:
measure: DLT
timeFrame: first cycle (28 days)
Secondary outcomes:
measure: Efficacy (M-protein)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Tokyo
country: Japan
facility: Keio University Hospital
Study officials:
affiliation: Celgene K.K.
name: Masaaki Takatoku, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.