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Paricalcitol and Zoledronate in Treating Patients With Relapsed or Refractory Multiple Myeloma or Other Plasma Cell Disorders

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
paricalcitol
zoledronic acid
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of relapsed or refractory multiple myeloma (MM) or other plasma cell disorder (PCD) At least one previous treatment for MM or PCD required PATIENT CHARACTERISTICS: Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy At least 3 months Hematopoietic Not specified Hepatic Not specified Renal Calcium ≤ 10.5 mg/dL No renal stone formation within the past 5 years for patients who have had curative therapy for a condition associated with the risk of stones (e.g., hyperparathyroidism, bladder dysfunction, obstructive uropathy) OR had a single episode of confirmed urolithiasis No calculi in urinary tract confirmed by renal ultrasonography, kidney, ureter, and bladder (KUB) x-ray, or other imaging modality Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No uncontrolled cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during study and for 3 months after study completion No osteonecrosis of the jaw No history of allergic reaction attributed to compounds of similar chemical or biological composition of calcitriol, paricalcitol, or zoledronate No uncontrolled intercurrent illness that would preclude study compliance No ongoing or active infection No psychiatric illness or social situation that may preclude study compliance PRIOR CONCURRENT THERAPY: Chemotherapy More than 4 weeks since prior chemotherapy Endocrine More than 4 weeks since prior high-dose steroids Other No other concurrent investigational agents or therapies for multiple myeloma or plasma cell disorders No concurrent digoxin

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 22, 2005
Last Updated
January 31, 2013
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00258258
Brief Title
Paricalcitol and Zoledronate in Treating Patients With Relapsed or Refractory Multiple Myeloma or Other Plasma Cell Disorders
Official Title
An Open Label Dose Escalation Study of Intravenous Paricalcitol (ZEMPLAR™) [19-NOR-1 ALPHA, 25 - (OH)D] With Zoledronic Acid (Zometa™) in Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Withdrawn due to low accrual
Study Start Date
August 2005 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
refractory multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paricalcitol
Intervention Type
Drug
Intervention Name(s)
zoledronic acid

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of relapsed or refractory multiple myeloma (MM) or other plasma cell disorder (PCD) At least one previous treatment for MM or PCD required PATIENT CHARACTERISTICS: Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy At least 3 months Hematopoietic Not specified Hepatic Not specified Renal Calcium ≤ 10.5 mg/dL No renal stone formation within the past 5 years for patients who have had curative therapy for a condition associated with the risk of stones (e.g., hyperparathyroidism, bladder dysfunction, obstructive uropathy) OR had a single episode of confirmed urolithiasis No calculi in urinary tract confirmed by renal ultrasonography, kidney, ureter, and bladder (KUB) x-ray, or other imaging modality Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No uncontrolled cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during study and for 3 months after study completion No osteonecrosis of the jaw No history of allergic reaction attributed to compounds of similar chemical or biological composition of calcitriol, paricalcitol, or zoledronate No uncontrolled intercurrent illness that would preclude study compliance No ongoing or active infection No psychiatric illness or social situation that may preclude study compliance PRIOR CONCURRENT THERAPY: Chemotherapy More than 4 weeks since prior chemotherapy Endocrine More than 4 weeks since prior high-dose steroids Other No other concurrent investigational agents or therapies for multiple myeloma or plasma cell disorders No concurrent digoxin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asher A. Chanan-Khan, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Paricalcitol and Zoledronate in Treating Patients With Relapsed or Refractory Multiple Myeloma or Other Plasma Cell Disorders

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