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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01698801
First received: October 1, 2012
Last updated: January 22, 2015
Last verified: January 2015
  Purpose

To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.


Condition Intervention Phase
Multiple Myeloma
Drug: Lenalidomide
Drug: dexamethasone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 26
Study Start Date: October 2012
Estimated Study Completion Date: June 2018
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide plus dexamethasone
Lenalidomide plus low-dose dexamethasone
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698801

Locations
Japan
Nagoya City University Hospital
Nagoya, Aichi, Japan, 467-8602
Nagoya Daini Red Cross Hospital
Nagoya, Aichi, Japan, 466-8650
Kameda Medical Center
Kamogawa, Chiba, Japan, 296-8602
Japanese Red Cross Narita Hospital
Narita, Chiba, Japan, 286-8523
Ehime University Hospital
Touon, Ehime, Japan, 791-0295
Nishigunma National Hospital
Shibukawa, Gunma, Japan, 377-8511
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan, 650-0047
Hitachi General Hospital
Hitachi, Ibaraki, Japan, 317-0077
Iwate Medical University
Morioka, Iwate, Japan, 020-8505
Tokai University Hospital
Isehara, Kanagawa, Japan, 259-1193
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Kurashiki Central Hospital
Kurashiki, Okayama, Japan, 710-8602
Kinki University Hospital, Faculty of Medicine
Osakasayama, Osaka, Japan, 589-8511
Shizuoka Cancer Center
Sunto, Shizuoka, Japan, 411-8777
National Disaster Medical Center
Tachikawa, Tokyo, Japan, 190-0014
Kagoshima Medical Center
Kagoshima, Japan, 892-0853
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Okayama Medical Center
Okayama, Japan, 701-1192
Osaka Red Cross Hospital
Osaka, Japan, 543-8555
Japanese Red Cross Medical Center
Tokyo, Japan, 150-8935
Keio University Hospital
Tokyo, Japan, 160-8582
National Cancer Center Hospital
Tokyo, Japan, 104-0045
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, Japan, 135-8550
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Toru Sasaki Celgene K.K.
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01698801     History of Changes
Other Study ID Numbers: CC-5013-MM-025
Study First Received: October 1, 2012
Results First Received: November 25, 2014
Last Updated: January 22, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Celgene Corporation:
Lenalidomide
dexamethasone
newly diagnosed multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 26, 2015