Skip to content

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

A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00039754
Enrollment
Unknown
Registered
2002-06-11
Start date
2002-03-31
Completion date
Unknown
Last updated
2009-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple myeloma, Transplant, Skeletal Targeted Radiotherapy, Holmium

Brief summary

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.

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).

Interventions

DRUGHolmium-166-DOTMP

Sponsors

Poniard Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026