Back to resultsStudy of ENMD-2076 in Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ENMD-2076
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Major Inclusion Criteria:
- Histological evidence of MM and evidence of relapse or refractory disease. Patients with non secretory myeloma or plasmacytoma only will be excluded.
- Patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents.
- Age ≥18 years.
- ECOG performance status 0-2.
- Patients must have adequate organ and marrow function
Major Exclusion Criteria:
- Prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug ENMD-2076.
- Prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis).
- Concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
- Have unstable angina pectoris or recent myocardial infarction (within 6 months.
- Have uncontrolled hypertension or congestive heart failure.
Sites / Locations
- Indiana University Melvin and Bren Simon Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ENMD-2076
Arm Description
Oral capsules, once daily in 28-day cycles
Outcomes
Primary Outcome Measures
Maximum tolerated dose of ENMD-2076
Secondary Outcome Measures
Correlative studies of activity
Clinical Benefit
Full Information
NCT ID
NCT00806065
First Posted
December 9, 2008
Last Updated
February 2, 2023
Sponsor
CASI Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00806065
Brief Title
Study of ENMD-2076 in Patients With Multiple Myeloma
Official Title
A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CASI Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Safety, tolerability, maximum tolerated dose and clinical benefit of ENMD-2076 administered over a range of doses in patients with relapsed or refractory multiple myeloma.
Detailed Description
The study is designed to assess the safety, tolerability, maximum tolerated dose, and clinical benefit of treatment with ENMD-2076 administered orally once daily over a range of doses in patients with relapsed or refractory multiple myeloma.
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
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ENMD-2076
Arm Type
Experimental
Arm Description
Oral capsules, once daily in 28-day cycles
Intervention Type
Drug
Intervention Name(s)
ENMD-2076
Primary Outcome Measure Information:
Title
Maximum tolerated dose of ENMD-2076
Time Frame
Within first 35 days
Secondary Outcome Measure Information:
Title
Correlative studies of activity
Time Frame
throughout the study period
Title
Clinical Benefit
Time Frame
Each cycle of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria:
Histological evidence of MM and evidence of relapse or refractory disease. Patients with non secretory myeloma or plasmacytoma only will be excluded.
Patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents.
Age ≥18 years.
ECOG performance status 0-2.
Patients must have adequate organ and marrow function
Major Exclusion Criteria:
Prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug ENMD-2076.
Prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis).
Concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
Have unstable angina pectoris or recent myocardial infarction (within 6 months.
Have uncontrolled hypertension or congestive heart failure.
Facility Information:
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of ENMD-2076 in Patients With Multiple Myeloma
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