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Completed

NCT Number: NCT00806065

Study of ENMD-2076 in Patients With 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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ENMD-2076

Drug

Primary outcomes

  1. Maximum tolerated dose of ENMD-2076

    Time frame: Within first 35 days

Secondary outcomes

  1. Correlative studies of activity

    Time frame: throughout the study period

  2. Clinical Benefit

    Time frame: Each cycle of treatment

Sponsors and collaborators

Lead sponsor

CASI pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Dec 10, 2008
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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