Know Cancer

or
forgot password

A Multicenter, Phase I Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma


Phase 1
20 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Multicenter, Phase I Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma


Inclusion Criteria:



- Subjects with previously treated multiple myeloma

- Measurable levels of m-protein in serum >= 0.5 g/dL [5g/L]) or urine (>= 0.2 g
excreted in a 24-hour collection sample)

- ECOG performance status of 0 - 2

- Willing to follow pregnancy precautions

Exclusion Criteria:

- Patients with acute an myocardial infarction (MI) within the past 6 months, or
patients with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
within the past 3 years

- Patients with tuberculous diseases, herpes simplex keratitis, systemic mycosis or
other active infectious diseases

- Patients with non-controlled diabetes, hypertension, digestive ulcer or glaucoma

- Patients with posterior subcapsular cataracts

- Patients with mental illness

- Patients with past histories or complications which make the Investigator or other
staff member deem them inappropriate for this study

- Pregnant or lactating females

- Grade 2 or worse neuropathy

- Any of the following laboratory abnormalities:

Absolute neutrophil count (ANC) < 1,000cells/mL Platelet count < 75,000/mL Serum
creatinine > 2.5 mg/dL Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)

- Prior history of malignancies, other than multiple myeloma, unless the subject has
been free of the disease for >= 3 years. - Patients who received radiation therapy
within 14 days of the start of study drug

- Patients with scars from a recent viscus operation

- Patients with history of a desquamating (blistering) rash while taking thalidomide

- Patients with prior use of lenalidomide

- Patients with known HIV positivity.

- Patients who used cytotoxic chemotherapeutic agents, immunomodulating agents, or
other experimental agents (agents that are not commercially available) intended for
the treatment of MM within 28 days of the start of lenalidomide therapy.

- Patients with known history of hypersensitivity to dexamethasone.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

DLT

Outcome Time Frame:

first cycle (28 days)

Safety Issue:

Yes

Principal Investigator

Masaaki Takatoku, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Celgene K.K.

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CC-5013-MM-017

NCT ID:

NCT00555100

Start Date:

July 2007

Completion Date:

December 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location