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| Title: | A Phase III Randomized Trial of Thalidomide plus Zoledronic Acid versus Zoledronic Acid Alone in Patients with Early Stage Multiple Myeloma
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| Phase: | III
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| Purpose: | To determine if thaliomide can delay progression of smoldering/indolent myeloma to symptomatic disease. All patients will receive zoledronic acid to prevent or delay bone lesions.
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| Eligibility: | Previously untreated asymptomatic MM. Patients cannot have received prior thalidomide, or corticosteroids, for the intent of treating their myeloma. Prior bisphosphonates are allowed as long as patients received no more than three doses in the last 12 months.
No immediate need for chemotherapy.
Measurable disease as defined by one of the following:
10% or higher plasma cells as measured on the bone marrow aspirate, bone marrow biopsy, or labeling index.
18 years or older.
Laboratory values obtained 21 days prior to registration:
Performance status 0, 1, or 2.
Willingness and ability to comply with the FDA mandated STEPS program if randomized to thalidomide.
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| Treatment: | Thalidomide plus Zoledronic acid versus Zoledronic acid.
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| Contact: |
Rochester, Minnesota
Mayo Clinic Cancer Center Contact: Melanie Thompson, 507-266-0733 (phone), thompson.melanie@mayo.edu Principal Investigator: Vincent Rajkumar, MD |
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| Please note: the trials indicated do not include the full inclusion or exclusion criteria. For full protocols, please contact the Principal Investigator (PI) listed. |
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