Paricalcitol and Zoledronate in Treating Patients With Relapsed or Refractory Multiple Myeloma or Other Plasma Cell Disorders
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ClinicalTrials.gov Identifier: NCT00258258 |
Recruitment Status :
Terminated
(Withdrawn due to low accrual)
First Posted : November 24, 2005
Last Update Posted : February 1, 2013
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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 |
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 (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 |


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

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 ClinicalTrials.gov identifier (NCT number): NCT00258258
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Principal Investigator: | Asher A. Chanan-Khan, MD | Roswell Park Cancer Institute |
Responsible Party: | Roswell Park Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00258258 |
Other Study ID Numbers: |
I 38504 RPCI-I-38504 NOVARTIS-RPCI-I-38504 ABBOTT-RPCI-I-38504 |
First Posted: | November 24, 2005 Key Record Dates |
Last Update Posted: | February 1, 2013 |
Last Verified: | January 2013 |
refractory multiple myeloma |
Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias |
Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Zoledronic Acid Bone Density Conservation Agents Physiological Effects of Drugs |