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COMPLETED Phase 1

Samarium Sm 153 Lexidronam Pentasodium and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT00478075 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to cancer cells and not harm normal cells. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Bortezomib may also make cancer cells more sensitive to radiation therapy. Giving samarium Sm 153 lexidronam pentasodium together with bortezomib may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with samarium Sm 153 lexidronam pentasodium and to see how well they work in treating patients with relapsed or refractory multiple myeloma.

Interventions

  • DRUG bortezomib
  • OTHER immunologic technique
  • RADIATION samarium Sm 153 lexidronam pentasodium

Study Locations (3)

Arizona

  • Mayo Clinic Scottsdale — Scottsdale

Florida

  • Mayo Clinic - Jacksonville — Jacksonville

Minnesota

  • Mayo Clinic Cancer Center — Rochester

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2005-09
Est. Completion 2009-06
Phase Phase 1

Sponsor

Mayo Clinic

3,246 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00478075

The ClinicalTrials.gov registry entry for NCT00478075 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 3,246 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Multiple Myeloma and Plasma Cell Neoplasm appearing as the primary indexed condition, and to 3 interventions — of which bortezomib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00478075 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Arizona, Florida, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00478075 about?

NCT00478075 is a clinical study titled "Samarium Sm 153 Lexidronam Pentasodium and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma". RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to cancer cells and not harm normal cells. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Bortez...

What is the current status of trial NCT00478075?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2005-09. Estimated completion is 2009-06.

What conditions does trial NCT00478075 study?

This clinical trial studies the following conditions: Multiple Myeloma and Plasma Cell Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00478075?

The interventions under investigation include: bortezomib (DRUG), immunologic technique (OTHER), samarium Sm 153 lexidronam pentasodium (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00478075?

This trial is sponsored by Mayo Clinic, which has 3,246 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00478075 being conducted?

This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial