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

• ClinicalTrials.gov Identifier: NCT00258258
• Recruitment Status: Terminated
• First Posted: November 24, 2005
• Last Update Posted: February 1, 2013
• Sponsor: Roswell Park Cancer Institute
• Information provided by (Responsible Party): Roswell Park Cancer Institute

Tracking Information

• First Submitted Date: November 22, 2005
• First Posted Date: November 24, 2005
• Last Update Posted Date: February 1, 2013
• Study Start Date: August 2005
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Myeloma and Plasma Cell Neoplasm

Intervention

• Drug: paricalcitol
• Drug: zoledronic acid

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 31, 2013): 7
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00258258
• Other Study ID Numbers: I 38504; RPCI-I-38504; NOVARTIS-RPCI-I-38504; ABBOTT-RPCI-I-38504
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Roswell Park Cancer Institute
• Study Sponsor: Roswell Park Cancer Institute
• Collaborators: Not Provided

Investigators

• Principal Investigator: Asher A. Chanan-Khan, MD; Roswell Park Cancer Institute

• PRS Account: Roswell Park Cancer Institute
• Verification Date: January 2013