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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00258258
Recruitment Status : Terminated (Withdrawn due to low accrual)
First Posted : November 24, 2005
Last Update Posted : February 1, 2013
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: paricalcitol Drug: zoledronic acid Phase 1

Detailed Description:



  • Determine the maximum tolerated dose of paricalcitol when used with zoledronate in patients with relapsed or refractory multiple myeloma or other plasma cell disorders.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Masking: None (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
Study Start Date : August 2005
Actual Primary Completion Date : March 2009

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of relapsed or refractory multiple myeloma (MM) or other plasma cell disorder (PCD)

    • At least one previous treatment for MM or PCD required


Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • At least 3 months


  • Not specified


  • Not specified


  • 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


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No uncontrolled cardiac arrhythmia


  • 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



  • More than 4 weeks since prior chemotherapy


  • More than 4 weeks since prior high-dose steroids


  • No other concurrent investigational agents or therapies for multiple myeloma or plasma cell disorders
  • No concurrent digoxin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00258258

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
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Principal Investigator: Asher A. Chanan-Khan, MD Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute Identifier: NCT00258258    
Other Study ID Numbers: I 38504
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013
Keywords provided by Roswell Park Cancer Institute:
refractory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs