Paricalcitol and Zoledronate in Treating Patients With Relapsed or Refractory Multiple Myeloma or Other Plasma Cell Disorders
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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 |
| Enrollment: | 7 |
| Study Start Date: | August 2005 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| 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 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 Ergocalciferols Zoledronic acid Diphosphonates Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 30, 2016