Trial record 28 of 406 for:
LENALIDOMIDE AND Dexamethasone
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 |
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Recruitment Status :
Completed
First Posted : October 3, 2012
Results First Posted : December 3, 2014
Last Update Posted : November 8, 2018
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Sponsor:
Celgene
Information provided by (Responsible Party):
Celgene
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Brief Summary:
To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Lenalidomide Drug: dexamethasone | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 26 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | October 1, 2012 |
| Actual Primary Completion Date : | November 26, 2013 |
| Actual Study Completion Date : | June 26, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lenalidomide plus dexamethasone
Lenalidomide plus low-dose dexamethasone
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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 |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698801
Locations
Show 24 study locations
Sponsors and Collaborators
Celgene
Investigators
| Study Director: | Toru Sasaki | Celgene K.K. |
Publications of Results:
| Responsible Party: | Celgene |
| ClinicalTrials.gov Identifier: | NCT01698801 |
| Other Study ID Numbers: |
CC-5013-MM-025 |
| First Posted: | October 3, 2012 Key Record Dates |
| Results First Posted: | December 3, 2014 |
| Last Update Posted: | November 8, 2018 |
| Last Verified: | October 2018 |
Keywords provided by Celgene:
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Lenalidomide dexamethasone newly diagnosed multiple myeloma |
Additional relevant MeSH terms:
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Dexamethasone Lenalidomide Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders |
Immune System Diseases Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Immunologic Factors Angiogenesis Inhibitors Angiogenesis Modulating Agents |