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Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
lenalidomide
dexamethasone
Sponsored by
Celgene
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nagoya City University Hospital
  • National Hospital Organization Nagoya Medical Center
  • Jichi Medical University Hospital
  • Niigata Cancer Center Hospital
  • Keio University Hospital

Outcomes

Primary Outcome Measures

DLT

Secondary Outcome Measures

Efficacy (M-protein)

Full Information

First Posted
November 6, 2007
Last Updated
November 7, 2019
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT00555100
Brief Title
Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2007 (Actual)
Primary Completion Date
December 1, 2010 (Actual)
Study Completion Date
December 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in Japanese subjects with previously treated MM. The study will consist of two cohorts: 1) Monotherapy "Maximum Tolerated Dose (MTD) Determination" Cohort; and 2) "Combination Treatment" Cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lenalidomide
Intervention Description
10mg-25mg PO/day,day1-day21 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
40mg PO/day, day1-4,9-12,17-20 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
DLT
Time Frame
first cycle (28 days)
Secondary Outcome Measure Information:
Title
Efficacy (M-protein)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaaki Takatoku, M.D.
Organizational Affiliation
Celgene K.K.
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
State/Province
Tochigi
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20559759
Citation
Iida S, Chou T, Okamoto S, Nagai H, Hatake K, Murakami H, Takagi T, Shimizu K, Lau H, Takeshita K, Takatoku M, Hotta T. Lenalidomide plus dexamethasone treatment in Japanese patients with relapsed/refractory multiple myeloma. Int J Hematol. 2010 Jul;92(1):118-26. doi: 10.1007/s12185-010-0624-7. Epub 2010 Jun 18. Erratum In: Int J Hematol. 2010 Jul;92(1):127-8.
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Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma

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