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


Phase 3
20 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety Adverse Events in the study period (20 months)

Outcome Time Frame:

End of Study

Safety Issue:

Yes

Principal Investigator

Masaaki Takatoku, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene KK

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CC-5013-MM-022

NCT ID:

NCT00928486

Start Date:

May 2009

Completion Date:

November 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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