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A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Multiple Myeloma


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

Thank you

Trial Information

A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Multiple Myeloma


Major

Inclusion Criteria:



1. Histological evidence of MM and evidence of relapse or refractory disease. Patients
with non secretory myeloma or plasmacytoma only will be excluded.

2. Patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or
ineligible to receive these agents.

3. Age ≥18 years.

4. ECOG performance status 0-2.

5. Patients must have adequate organ and marrow function

Major Exclusion Criteria:

1. Prior cytotoxic chemotherapy or investigational agent within 28 days or autologous
stem cell transplant within 6 months of receiving study drug ENMD-2076.

2. Prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis).

3. Concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone
(or equivalent) if given for management of co-morbid conditions.

4. Have unstable angina pectoris or recent myocardial infarction (within 6 months.

5. Have uncontrolled hypertension or congestive heart failure.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of ENMD-2076

Outcome Time Frame:

Within first 35 days

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

2076-CL-002

NCT ID:

NCT00806065

Start Date:

December 2008

Completion Date:

January 2012

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289