Multiple Myeloma and Plasma Cell Neoplasm
Conditions
Keywords
refractory 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.
Interventions
DRUGparicalcitol
DRUGzoledronic acid
Sponsors
Roswell Park Cancer Institute
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed