We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Skeletal Targeted Radiotherapy Using Holmium-166-DOTMP in Patients With Multiple Myeloma

This study has been terminated.
(business reasons)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00039754
First Posted: June 11, 2002
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Poniard Pharmaceuticals
  Purpose
Multiple myeloma is a disease that resides primarily in the bone and has shown to be sensitive to radiation. Administration of a radiotherapy agent that targets the bone, such as Holmium-166-DOTMP, in conjunction with melphalan and an autologous stem cell transplant, may improve the patient's chance of responding to treatment. The purpose of this study is to determine the amount of Holmium-166-DOTMP that localizes in the bone and in normal organs, and to evaluate the safety and efficacy of Holmium-166-DOTMP in the treatment of patients with multiple myeloma.

Condition Intervention Phase
Multiple Myeloma Drug: Holmium-166-DOTMP Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Poniard Pharmaceuticals:

Study Start Date: March 2002
Detailed Description:
The purpose of this study is to estimate the radiation absorbed dose to the bone marrow and kidneys based on whole-body gamma camera image data for comparison with that obtained using mathematical models based on whole body counting from a small gamma detection device called a thyroid probe; to obtain pharmacokinetic data following administration of 166Ho-DOTMP; and to evaluate safety and efficacy in patients who receive 25 Gy targeted therapy of 166Ho-DOTMP and 200 mg/m2 melphalan followed by autologous peripheral blood stem cell transplant (PBSCT).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00039754     History of Changes
Other Study ID Numbers: 0102
First Submitted: June 7, 2002
First Posted: June 11, 2002
Last Update Posted: January 21, 2009
Last Verified: January 2009

Keywords provided by Poniard Pharmaceuticals:
Multiple myeloma
Transplant
Skeletal Targeted Radiotherapy
Holmium

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases