Clinical trial NCT01698801: A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma
Official title: A Phase 2, Multicenter, Open-label, Single Arm Study of Lenalidomide (CC-5013) in Combination With Low-dose Dexamethasone in Japanese Patients With Previously Untreated Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Lenalidomide
dexamethasone
newly diagnosed multiple myeloma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2012-10-03
Enrollment: 26
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 determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 20 years at the time of signing the informed consent document
* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
* Able to adhere to the study visit schedule and other protocol requirements
* Previously untreated, symptomatic multiple myeloma
* Have measurable disease by protein electrophoresis analyses
* At least 65 years of age or older or, if younger than 65 years of age, not candidates for hematopoietic stem cell transplantation
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan

Exclusion Criteria:

* Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
* Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
* Any condition that confounds the ability to interpret data from the study
* Previous treatment with anti-myeloma therapy
* Pregnant or lactating females
* Any of the following laboratory abnormalities:

  * Absolute neutrophil count (ANC) \< 1,000/microL (1.0 × 10\^9/L )
  * Untransfused platelet count (a platelet count drawn at least 7 days after the administration of the last platelet transfusion) \< 50,000 cells/microL (50 × 10\^9/L)
  * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3.0 × upper limit of normal
* Renal failure requiring hemodialysis or peritoneal dialysis
* Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years
* Subjects who are unable or unwilling to undergo antithrombotic therapy.
* Peripheral neuropathy of ≥ grade 2 severity.
* Uncontrolled systemic fungal, bacterial, or viral infection
* Known human immunodeficiency virus (HIV) positivity (subjects who are receiving antiretroviral therapy for HIV disease)
* Hepatitis Bs (HBs) antigen-positive, or hepatitis C virus (HCV) antibody-positive. In case HBc antibody and/or HBs antibody is positive even if HBs antigen-negative, a Hepatitis B virus (HBV) DNA test should be performed and if positive the subject will be excluded.
* Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
* Ineligible for dexamethasone or dexamethasone is contraindicated.

Primary outcomes:
measure: Overall Response Rate
timeFrame: From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.
Secondary outcomes:
measure: Time to Response
timeFrame: From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks.
measure: Duration of Response
timeFrame: From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks.
measure: Progression Free Survival (PFS)
timeFrame: From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks.
measure: Overall Survival (OS)
timeFrame: From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months
measure: Number of Participants With Adverse Events
timeFrame: From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya Daini Red Cross Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Kamogawa
country: Japan
facility: Kameda Medical Center
state: Chiba
city: Narita
country: Japan
facility: Japanese Red Cross Narita Hospital
state: Chiba
city: Touon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Shibukawa
country: Japan
facility: Nishigunma National Hospital
state: Gunma
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Hitachi
country: Japan
facility: Hitachi General Hospital
state: Ibaraki
city: Morioka
country: Japan
facility: Iwate Medical University
state: Iwate
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Osakasayama
country: Japan
facility: Kinki University Hospital, Faculty of Medicine
state: Osaka
city: Sunto
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Tachikawa
country: Japan
facility: National Disaster Medical Center
state: Tokyo
city: Kagoshima
country: Japan
facility: Kagoshima Medical Center
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama Medical Center
city: Osaka
country: Japan
facility: Osaka Red Cross Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research
city: Tokyo
country: Japan
facility: Japanese Red Cross Medical Center
city: Tokyo
country: Japan
facility: Keio University Hospital
Study officials:
affiliation: Celgene K.K.
name: Toru Sasaki
role: STUDY_DIRECTOR
References:
citation: Suzuki K, Shinagawa A, Uchida T, Taniwaki M, Hirata H, Ishizawa K, Matsue K, Ogawa Y, Shimizu T, Otsuka M, Matsumoto M, Iida S, Terui Y, Matsumura I, Ikeda T, Takezako N, Ogaki Y, Midorikawa S, Houck V, Ervin-Haynes A, Chou T. Lenalidomide and low-dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma: A phase II study. Cancer Sci. 2016 May;107(5):653-8. doi: 10.1111/cas.12916. Epub 2016 Mar 30.