A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Subjects With Previously Treated Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00928486
First received: June 9, 2009
Last updated: January 26, 2011
Last verified: January 2011
  Purpose

To evaluate the safety and efficacy of lenalidomide with dexamethasone in Japanese subjects with previously treated multiple myeloma.


Condition Intervention Phase
Multiple Myeloma
Drug: CC-5013 (lenalidomide)
Drug: dexamethasone
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Safety Confirmation Study On Lenalidomide With Dexamethasone In Japanese Subjects With Previously Treated Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Safety Adverse Events in the study period (20 months) [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy (M-protein in the study period 20 months) [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: May 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CC-5013 (lenalidomide)
    initial dose 25mg for one cycle (days 1 - 21)
    Drug: dexamethasone
    40 mg once daily on days 1 -4 , 9 - 12 and 17 - 20 of each cycle
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must understand and voluntarily sign the informed consent form
  • Age ≥ 20 years at the time of signing the informed consent form
  • Subjects with previously treated multiple myeloma defined as follows:

    • Subjects must have received at least 1 prior anti-myeloma drug treatment regimen; and
    • Considered to have progression of disease (PD) that occurred either during or following the completion of the last anti-myeloma treatment regimen utilized prior to enrollment into this study
  • Measurable levels of M-protein in serum (greater than or equal to 0.5 g/dL [5g/L]) or urine (greater than or equal to 0.2 g excreted in a 24-hour collection sample)
  • ECOG performance status of 0 - 2
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Females of childbearing potential (FCBP) must agree to use one or more of the following forms of contraception or abstain from heterosexual contact completely and have the male partners use a condom on the occasion of heterosexual contact in the following periods below:

    • For at least 28 days before starting study drug (in particular, the subject must abstain from heterosexual contact for 2 weeks prior to prescribing lenalidomide).
    • During the treatment phase (including the dose withholding period) For at least 28 days after the discontinuation/completion of the study drug (Methods of contraception)
    • Birth control pills
    • Intrauterine device (IUD)
    • Bilateral tubal ligation (FCBP must be referred to a health care provider who is familiar with contraceptive methods, if needed).
  • Male subject must agree to use a condom during sexual contact with female irrespective of pregnancy potential
  • Subjects must agree that study drug must be immediately discontinued, if pregnancy or a positive pregnancy test does occur in a female study subject or the partner of a male study subject during study participation

Exclusion Criteria:

  • Pregnant or lactating females
  • Subjects with a history of acute myocardial infarction within the past 6 months before starting the study drugs
  • Subjects with any history or concurrent conditions of deep vein thrombosis or pulmonary embolus within the past 3 years before starting study drugs
  • Subjects with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases
  • Subjects with non-controlled diabetes, hypertension, digestive ulcer or glaucoma
  • Subjects with posterior subcapsular cataracts
  • Subjects with peripheral neuropathy of ≥Grade 2
  • Subjects with any history or concurrent conditions which the Principal Investigator / subinvestigators consider inappropriate for participation in this study, and subjects with a serious disease or a mental disease, which is considered to become more risky if the subjects participate in this study.
  • Subjects with a history of desquamative (blistering) rash while taking thalidomide
  • Subjects with a history of using lenalidomide
  • Subjects who have used thalidomide within 28 days before starting the study drugs
  • Subjects with a history of hypersensitivity to dexamethasone
  • Subjects who discontinued treatment due to grade 3 or 4 toxicity from high dose dexamethasone
  • Subjects with a surgical wound after a visceral surgery performed recently
  • Subjects who have undergone radiation therapy within 14 days before starting the study drugs
  • Subjects who have used a chemotherapeutic agent, an immunomodulating agent or a study drug (a drug not commercially available) intended for the treatment of MM within 28 days before starting the study drug
  • Subjects with any history or concurrent conditions of malignancies, other than MM, unless the subject has been free of the disease for 3 years:

    • Basal cell carcinoma of the skin,
    • Squamous cell carcinoma of the skin,
    • Carcinoma in situ of the cervix,
    • Carcinoma in situ of the breast,
    • Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
  • Known HIV infection or HIV-1 positivity
  • Subjects who have been diagnosed as an HBV carrier
  • Subjects who are applicable to any of the following abnormal laboratory findings:

    • Absolute neutrophil count : < 1,000 /μL (1.0×109 /L)
    • Platelet count: <75,000 /μL (75×109 /L)
    • AST/SGOT or ALT/SGPT: > 3.0 times the upper limit of the standard range
    • Creatinine clearance: < 30 mL/min
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928486

Locations
Japan
Nagoya Medical Center
Nagoya-city, Aichi, Japan, 460-0001
Nagoya City University Hospital
Nagoya-city, Aichi, Japan, 467-8602
Fukuoka University Hospital
Fukuoka-city, Fukuoka, Japan, 814-0180
Kyoto Prefectural University of Medicine
Kyoto-city, Kyoto, Japan, 602-8566
Niigata Cancer Center Hospital
Niigata-city, Niigata, Japan, 951-5866
Osaka Red Cross Hospital
Osaka-city, Osaka, Japan, 543-8555
Tokushima University
Tokushima-city, Tokushima, Japan, 770-8503
Keio University Hospital
Tokyo, Japan, 160-8582
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Masaaki Takatoku, MD Celgene KK
  More Information

No publications provided

Responsible Party: President Joseph Melillo, Celgene K.K
ClinicalTrials.gov Identifier: NCT00928486     History of Changes
Other Study ID Numbers: CC-5013-MM-022
Study First Received: June 9, 2009
Last Updated: January 26, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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
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
Hormones

ClinicalTrials.gov processed this record on April 15, 2014