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

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: paricalcitol Drug: zoledronic acid	Phase 1


Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Zoledronic acid Paricalcitol

Genetic and Rare Diseases Information Center resources: Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:


Enrollment:	7
Study Start Date:	August 2005
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258258

Locations


United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators


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

More Information

No publications provided


Responsible Party:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00258258 History of Changes
Other Study ID Numbers:	I 38504, RPCI-I-38504, NOVARTIS-RPCI-I-38504, ABBOTT-RPCI-I-38504
Study First Received:	November 22, 2005
Last Updated:	January 31, 2013
Health Authority:	United States: Federal Government

Keywords provided by Roswell Park Cancer Institute:


refractory multiple myeloma

Additional relevant MeSH terms:


Multiple Myeloma Neoplasms, Plasma Cell Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders	Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Paraproteinemias Vascular Diseases Zoledronic acid Bone Density Conservation Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015