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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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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 InstituteBuffalo, New York  14263