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
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Asher A. Chanan-Khan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Federal Government
Study ID:
I 38504
NCT ID:
NCT00258258
Start Date:
August 2005
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- refractory multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
