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 30, 2014
Last verified: January 2014
  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: 6 months ] [ Designated as safety issue: No ]
    Number of Complete Response (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria


Secondary Outcome Measures:
  • Time to Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events

  • Progression Free Survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
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 × 109/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 × 109/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 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 Daini Red Cross Hospital
Nagoya, Aichi, Japan, 466-8650
Nagoya City University Hospital
Nagoya, Aichi, Japan, 467-8602
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
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, Japan, 135-8550
National Cancer Center Hospital
Tokyo, Japan, 104-0045
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
Last Updated: January 30, 2014
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
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
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on July 22, 2014