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Status:

COMPLETED

Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma

Lead Sponsor:

Mayo Clinic

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Multiple Myeloma and Plasma Cell Neoplasm

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Zoledronate may prevent bone loss and stop the growth of cancer cells in bone. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet know wheth...

Detailed Description

OBJECTIVES: Primary * Compare time to progression in patients with early stage multiple myeloma treated with zoledronate with or without thalidomide. Secondary * Compare the response rate, 1-year ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of multiple myeloma (MM)
  • Previously untreated asymptomatic disease
  • No requirement for immediate chemotherapy for active MM, such as hypercalcemia from myeloma or painful bone lesions
  • No solitary plasmacytoma
  • Measurable or evaluable disease as defined by one of the following:
  • Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
  • More than 200 mg of monoclonal protein in the urine by 24-hour electrophoresis
  • Measurable soft tissue plasmacytoma by physical exam with ruler or by MRI or positron emission tomography/CT scan
  • If the only measurable lesion is the plasmacytoma, it must be ≥ 1.5 cm in 1 dimension
  • Must have ≥ 10% plasma cells as measured on the bone marrow aspirate, bone marrow biopsy, or labeling index
  • No amyloidosis
  • PATIENT CHARACTERISTICS:
  • Performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL
  • Creatinine ≤ 2.0 mg/dL (elevation above normal range should not be felt to be related to myeloma)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 4 weeks after completion of study treatment
  • No uncontrolled infection
  • No other active malignancy
  • No New York Heart Association class III or IV heart disease
  • No pre-existing neuropathy ≥ grade 2
  • No concurrent major dental work
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Prior corticosteroids (for nonmalignant disorders) allowed
  • Prior therapy with experimental agents not shown to have significant activity in MM, such as clarithromycin, dehydroepiandrosterone, and anakinra allowed
  • No prior thalidomide or corticosteroids for MM
  • No more than 3 doses of IV zoledronate or pamidronate within the past 12 months
  • At least 3 months since prior radiotherapy, including radiotherapy for solitary plasmacytoma
  • No concurrent oral bisphosphonate therapy for osteoporosis

Exclusion

    Key Trial Info

    Start Date :

    July 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2012

    Estimated Enrollment :

    68 Patients enrolled

    Trial Details

    Trial ID

    NCT00432458

    Start Date

    July 1 2003

    End Date

    April 1 2012

    Last Update

    July 4 2012

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259-5499

    2

    Mayo Clinic - Jacksonville

    Jacksonville, Florida, United States, 32224

    3

    Mayo Clinic Cancer Center

    Rochester, Minnesota, United States, 55905

    4

    Memorial Sloan-Kettering Cancer Center

    New York, New York, United States, 10065