Multiple Myeloma
Conditions
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.
Interventions
DRUGENMD-2076
Sponsors
CASI Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose of ENMD-2076 | Within first 35 days |
Secondary
| Measure | Time frame |
|---|---|
| Correlative studies of activity | throughout the study period |
| Clinical Benefit | Each cycle of treatment |
Countries
United States
Outcome results
None listed