Study of ENMD-2076 in Patients With Multiple Myeloma

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: ENMD-2076

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin and Bren Simon Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ENMD-2076; Oral capsules, once daily in 28-day cycles	Drug: ENMD-2076

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum tolerated dose of ENMD-2076	Within first 35 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlative studies of activity	throughout the study period
Clinical Benefit	Each cycle of treatment

Collaborators and Investigators

• Sponsor: CASI pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: December 9, 2008
• First Submitted That Met QC Criteria: December 9, 2008
• First Posted (ESTIMATE): December 10, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 2076-CL-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO