Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482378
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2007-06-04
Brief Title:
Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
An Open-Label Pilot Study of Samarium - Sm 153 Lexidronam Quadramet in Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radioactive drugs such as samarium Sm 153 lexidronam pentasodium may carry radiation directly to cancer cells and not harm normal cells Zoledronic acid and pamidronate may help relieve bone pain caused by multiple myeloma Giving samarium Sm 153 lexidronam pentasodium together with zoledronic acid or pamidronate may be an effective treatment for multiple myeloma
PURPOSE This phase III trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with zoledronic acid or pamidronate and to see how well it works in treating patients with relapsed or refractory multiple myeloma and bone pain
PURPOSE This phase III trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with zoledronic acid or pamidronate and to see how well it works in treating patients with relapsed or refractory multiple myeloma and bone pain
Detailed Description:
OBJECTIVES
Primary
Determine the safety and tolerability of samarium Sm 153 lexidronam pentasodium in combination with zoledronic acid or pamidronate disodium in patients with relapsed or refractory multiple myeloma and bone pain Phase I
Determine the clinical response in patients treated with these regimens Phase II
Secondary
Determine the effect of these regimens on changes in patient-reported bone pain levels
OUTLINE This is a multicenter open-label pilot phase I dose-escalation study of samarium Sm 153 lexidronam pentasodium followed by a phase II study
Phase I Patients receive samarium Sm 153 lexidronam pentasodium IV over 1 minute on day 1 Patients also receive zoledronic acid IV over 15 minutes or pamidronate disodium IV over 2-4 hours on day 1 and then monthly thereafter in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of samarium Sm 153 lexidronam pentasodium until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive samarium Sm 153 lexidronam pentasodium at the MTD determined in phase I and zoledronic acid or pamidronate disodium as in phase I
Bone pain is assessed periodically
After completion of study treatment patients are followed every 3-6 months for up to 3 years
Primary
Determine the safety and tolerability of samarium Sm 153 lexidronam pentasodium in combination with zoledronic acid or pamidronate disodium in patients with relapsed or refractory multiple myeloma and bone pain Phase I
Determine the clinical response in patients treated with these regimens Phase II
Secondary
Determine the effect of these regimens on changes in patient-reported bone pain levels
OUTLINE This is a multicenter open-label pilot phase I dose-escalation study of samarium Sm 153 lexidronam pentasodium followed by a phase II study
Phase I Patients receive samarium Sm 153 lexidronam pentasodium IV over 1 minute on day 1 Patients also receive zoledronic acid IV over 15 minutes or pamidronate disodium IV over 2-4 hours on day 1 and then monthly thereafter in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of samarium Sm 153 lexidronam pentasodium until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive samarium Sm 153 lexidronam pentasodium at the MTD determined in phase I and zoledronic acid or pamidronate disodium as in phase I
Bone pain is assessed periodically
After completion of study treatment patients are followed every 3-6 months for up to 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA015083 | NIH | None | None |
| MC048B | OTHER | None | None |
| 261-05 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |