Please select the eligibility criteria that correspond to the clinical trial below.
Title: UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma
Brief Summary: The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate or thalidomide and Zometa is in controlling the myeloma disease and to study any side effects.


Options:
A: 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
B: Inclusion Criteria:

* Patients must have a diagnosis of Smoldering or Indolent myeloma
* All patients must be informed of the investigational nature of this study and must sign a written informed consent in accordance with UAMS Human Research Advisory Committee and federal guidelines.

Exclusion Criteria:

* Prior bisphosphonate therapy within 30 days prior to study entry.
* Serum creatinine \> 5 mg/dl, ascites, or serum direct bilirubin \> 2.5 mg/dl.
* Prior plicamycin or calcitonin within 2 weeks of study entry.
* Severe cardiac disease, unstable thyroid disease, or epilepsy.
* Prior radiation therapy to \> 20% of the skeleton.
C: Inclusion Criteria:

* Men \>/= 18 years of age with histologically confirmed prostate cancer
* Radiographic evidence of at least one bone metastasis
* Failure of at least one hormonal therapy as evidenced by a rising PSA
* Serum testosterone level of \<50 ng/dL
* ECOG PS 0, 1, or 2
* Adequate organ function

Exclusion Criteria:

* Current or prior IV bisphosphonate administration
* Current or prior oral bisphosphonates for bone mets
* Life expectancy of less than 6 months
D: Inclusion Criteria:

* New diagnosed multiple myeloma with treatment demanding disease

Exclusion Criteria:

* Life-expectancy less than 3 months, another active malignant disease, treatment with bisphosphonates for more than 3 months within the last 6 months, patients with creatinine above 400 µmol/l 4 weeks after starting chemotherapy, patients who cannot cooperate for monthly infusions, patients who do not give their informed consent

Answer: B