Paricalcitol and Zoledronate in Treating Patients With Relapsed or Refractory Multiple Myeloma or Other Plasma Cell Disorders

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: Diphosphonates; Ergocalciferols; Zoledronic Acid

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