Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
Condition: Breast Adenocarcinoma; DS Stage I Plasma Cell Myeloma; DS Stage II Plasma Cell Myeloma; Metastatic Malignant Neoplasm to the Bone; Pain; Musculoskeletal Complication; Urinary Complications
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Adenocarcinoma; Neoplasms
Intervention: zoledronic acid
Intervention description: Given IV
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1822.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pain; Prostate Adenocarcinoma; urinary complications; stage IV breast cancer; Recurrent Breast Carcinoma; stage IV prostate cancer; recurrent prostate cancer; Recurrent Prostate Carcinoma; stage I multiple myeloma; stage II multiple myeloma; Refractory Plasma Cell Myeloma; bone metastases

Summary:

      This randomized phase III trial studies two different schedules of zoledronic acid to compare
      how well they work in reducing bone-related complications in patients with breast cancer,
      prostate cancer, or multiple myeloma that has spread to other places in the body and have
      bone involvement. Bone-related complications are a major cause of morbidity in patients with
      metastatic prostate cancer, breast cancer, and multiple myeloma. Zoledronic acid may stop the
      growth of cancer cells in the bone and may help relieve some of the symptoms caused by bone
      metastases. It is not yet known whether giving zoledronic acid more or less frequently is
      more effective in treating patients with metastatic cancer that has spread to the bone.
    

Eligibility criteria:

        Eligibility Criteria:

          -  Histologic documentation of one of the following: breast adenocarcinoma, prostate
             adenocarcinoma or multiple myeloma

          -  At least one site of bone metastasis or bone involvement by radiologic imaging
             including plain radiograph, computed tomography (CT), positron emission tomography
             (PET) scan, PET/CT scan, magnetic resonance imaging, bone scan, or skeletal survey;
             indeterminate lesions should be confirmed by a second imaging method

          -  No prior treatment with IV bisphosphonates is allowed; prior treatment with oral
             bisphosphonates is allowed, but they must be discontinued prior to the initiation of
             protocol therapy

          -  No prior treatment with denosumab

          -  No prior treatment with radiopharmaceuticals; prior treatment with radioactive iodine
             is allowed; prostate cancer patients treated with brachytherapy are eligible

          -  Prior radiation therapy to bone is allowed, provided that at least one site of bone
             metastasis has not been irradiated and radiation is completed prior to registration;
             there should be no plan for radiation therapy to non-irradiated sites of bone
             metastases

          -  Prior adjuvant and metastatic chemotherapy, biologic therapy, and endocrine therapy is
             allowed

          -  No current treatment with investigational agent(s)

          -  Patients with known brain metastases are not eligible; patients who develop brain
             metastases during the study will be allowed to continue treatment as assigned

          -  Not pregnant and not nursing

          -  ECOG performance status 0-2

          -  Calculated creatinine clearance >= 30 mL/min

          -  Corrected serum calcium >= 8.0 mg/dL (2.00 mmol/L) and < 11.6 mg/dL (2.90 mmol/L) *
             Corrected serum calcium should be calculated using standard institutional practices