Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258258
Status:
TERMINATED
Last Update Posted:
2013-02-01
First Post:
2005-11-22
Brief Title:
Paricalcitol and Zoledronate in Treating Patients With Relapsed or Refractory Multiple Myeloma or Other Plasma Cell Disorders
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
An Open Label Dose Escalation Study of Intravenous Paricalcitol ZEMPLAR 19-NOR-1 ALPHA 25 - OHD With Zoledronic Acid Zometa in Patients With Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Paricalcitol may cause multiple myeloma cells to look more like normal cells and to grow and spread more slowly Paricalcitol may also stop the growth of the cancer cells by blocking blood flow to the cancer Zoledronate may delay or prevent bone metastases in patients with multiple myeloma Giving paricalcitol together with zoledronate may be an effective treatment for multiple myeloma or other plasma cell disorders
PURPOSE This clinical trial is studying the side effects and best dose of paricalcitol when given with zoledronate in treating patients with relapsed or refractory multiple myeloma or other plasma cell disorders
PURPOSE This clinical trial is studying the side effects and best dose of paricalcitol when given with zoledronate in treating patients with relapsed or refractory multiple myeloma or other plasma cell disorders
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of paricalcitol when used with zoledronate in patients with relapsed or refractory multiple myeloma or other plasma cell disorders
Secondary
Determine the toxic effects of this regimen in these patients
Determine the antimyeloma activity of paricalcitol in patients treated with this regimen
OUTLINE This is an open-label dose-escalation study of paricalcitol
Patients receive paricalcitol IV over 15 minutes on days 1 8 and 15 and zoledronate IV over 15 minutes on day 22 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paricalcitol 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
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of paricalcitol when used with zoledronate in patients with relapsed or refractory multiple myeloma or other plasma cell disorders
Secondary
Determine the toxic effects of this regimen in these patients
Determine the antimyeloma activity of paricalcitol in patients treated with this regimen
OUTLINE This is an open-label dose-escalation study of paricalcitol
Patients receive paricalcitol IV over 15 minutes on days 1 8 and 15 and zoledronate IV over 15 minutes on day 22 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paricalcitol 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
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study
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 |
|---|---|---|---|
| RPCI-I-38504 | None | None | None |
| NOVARTIS-RPCI-I-38504 | None | None | None |
| ABBOTT-RPCI-I-38504 | None | None | None |