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A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01698801
Recruitment Status : Completed
First Posted : October 3, 2012
Results First Posted : December 3, 2014
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE October 1, 2012
First Posted Date  ICMJE October 3, 2012
Results First Submitted Date  ICMJE November 25, 2014
Results First Posted Date  ICMJE December 3, 2014
Last Update Posted Date November 8, 2018
Actual Study Start Date  ICMJE October 1, 2012
Actual Primary Completion Date November 26, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
Overall Response Rate [ Time Frame: From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks. ]
Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder. CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
Overall Response Rate [ Time Frame: 6 months ]
Number of Complete Response (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria
Change History Complete list of historical versions of study NCT01698801 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
  • Time to Response [ Time Frame: 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. ]
    Time to response was calculated for the responders as the time from the first dose date to the initial documented response (CR, VGPR or PR). CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.
  • Duration of Response [ Time Frame: 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. ]
    Duration of response was calculated for the responders as the time from the initial documented response (CR or VGPR or PR) to the first documented progression or death due to any cause, whichever occurred first. Duration of response for participants last known to be alive with no progression after a CR, VGPR, or PR were censored at the date of last adequate response assessment.
  • Progression Free Survival (PFS) [ Time Frame: 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. ]
    PFS was calculated as the time from the first dose date to the first documented progression based on IWG criteria or death due to any cause, whichever occurred first. If progression or death was not documented at the time of data cutoff date, these observations were censored at the last adequate assessment date showing evidence of no progression or death.
  • Overall Survival (OS) [ Time Frame: 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 ]
    The time from the start of study treatment to death due to any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
  • Number of Participants With Adverse Events [ Time Frame: 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 ]
    An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
  • Time to Response [ Time Frame: 6 months ]
    Time to response will be calculated for the responders as the time from the start of study treatment to the initial documented response.
  • Duration of Response [ Time Frame: 6 months ]
    Duration of response will be calculated for the responders as the time from the initial documented response (CR or VGPR or PR) to the first documented progression
  • Adverse Event [ Time Frame: Up to 5 years ]
    Number of participants with adverse events
  • Progression Free Survival (PFS) [ Time Frame: 6 months ]
    The time from the start of study treatment to the first documented progression or death due to any cause, whichever occurs first. The progression date will be assigned to the earliest time when any progression is observed. If withdrawal from the study due to adverse events or change of therapy occurs before documented progression or death, then these observations will be censored at the date when the last complete myeloma response assessment determines a lack of progression. For subjects who do not develop PD during the study, if the response from the last visit is 'not evaluable', the most prior visit date with a complete evaluation indicating no PD will be used as the censor date. Sensitivity analyses will be performed based on different censoring rules for PFS, which will be specified in the statistical analysis plan.
  • Overall Survival [ Time Frame: Up to five years ]
    The time from the start of study treatment to death due to any cause. OS will be censored at the last date that the subject was known to be alive for subject who were alive at the time of analysis and for subject who were lost to follow-up before death was documented.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma
Official Title  ICMJE 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
Brief Summary To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: Lenalidomide
    25 mg oral lenalidomide once daily on Days 1-21 of each 28-day cycle
    Other Name: Revlimid
  • Drug: dexamethasone
    40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle
    Other Name: LenaDex
Study Arms  ICMJE Experimental: Lenalidomide plus dexamethasone
Lenalidomide plus low-dose dexamethasone
Interventions:
  • Drug: Lenalidomide
  • Drug: dexamethasone
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2014)
26
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2012)
20
Actual Study Completion Date  ICMJE June 26, 2018
Actual Primary Completion Date November 26, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01698801
Other Study ID Numbers  ICMJE CC-5013-MM-025
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Toru Sasaki Celgene K.K.
PRS Account Celgene
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP