Status:
TERMINATED
Paricalcitol and Zoledronate in Treating Patients With Relapsed or Refractory Multiple Myeloma or Other Plasma Cell Disorders
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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. Second...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00258258
Start Date
August 1 2005
Last Update
February 1 2013
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001