Back to resultsA Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Lenalidomide
dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Lenalidomide, dexamethasone, newly diagnosed 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.
Sites / Locations
- Nagoya Daini Red Cross Hospital
- Nagoya City University Hospital
- Kameda Medical Center
- Japanese Red Cross Narita Hospital
- Ehime University Hospital
- Nishigunma National Hospital
- Kobe City Medical Center General Hospital
- Hitachi General Hospital
- Iwate Medical University
- Tokai University Hospital
- Tohoku University Hospital
- Kurashiki Central Hospital
- Kinki University Hospital, Faculty of Medicine
- Shizuoka Cancer Center
- National Disaster Medical Center
- Kagoshima Medical Center
- University Hospital, Kyoto Prefectural University of Medicine
- Niigata Cancer Center Hospital
- Okayama Medical Center
- Osaka Red Cross Hospital
- National Cancer Center Hospital
- The Cancer Institute Hospital of Japanese Foundation for Cancer Research
- Japanese Red Cross Medical Center
- Keio University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lenalidomide plus dexamethasone
Arm Description
Lenalidomide plus low-dose dexamethasone
Outcomes
Primary Outcome Measures
Overall Response Rate
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.
Secondary Outcome Measures
Time to Response
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
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)
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)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01698801
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2012 (Actual)
Primary Completion Date
November 26, 2013 (Actual)
Study Completion Date
June 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Lenalidomide, dexamethasone, newly diagnosed multiple myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lenalidomide plus dexamethasone
Arm Type
Experimental
Arm Description
Lenalidomide plus low-dose dexamethasone
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
25 mg oral lenalidomide once daily on Days 1-21 of each 28-day cycle
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
LenaDex
Intervention Description
40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
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.
Time Frame
From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.
Secondary Outcome Measure Information:
Title
Time to Response
Description
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.
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.
Title
Duration of Response
Description
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.
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.
Title
Progression Free Survival (PFS)
Description
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.
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.
Title
Overall Survival (OS)
Description
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.
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
Title
Number of Participants With Adverse Events
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toru Sasaki
Organizational Affiliation
Celgene K.K.
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya Daini Red Cross Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Kameda Medical Center
City
Kamogawa
State/Province
Chiba
ZIP/Postal Code
296-8602
Country
Japan
Facility Name
Japanese Red Cross Narita Hospital
City
Narita
State/Province
Chiba
ZIP/Postal Code
286-8523
Country
Japan
Facility Name
Ehime University Hospital
City
Touon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Nishigunma National Hospital
City
Shibukawa
State/Province
Gunma
ZIP/Postal Code
377-8511
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Hitachi General Hospital
City
Hitachi
State/Province
Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
Iwate Medical University
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Kinki University Hospital, Faculty of Medicine
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Sunto
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Disaster Medical Center
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0014
Country
Japan
Facility Name
Kagoshima Medical Center
City
Kagoshima
ZIP/Postal Code
892-0853
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Osaka Red Cross Hospital
City
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26914369
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.
Results Reference
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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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