At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of smoldering or indolent myeloma
- ✕Prior bisphosphonate therapy within 30 days
- ✕Serum creatinine >5 mg/dl, ascites, or serum direct bilirubin >2.5 mg/dl
- ✕Prior plicamycin or calcitonin within 2 weeks
- ✕Severe cardiac disease, unstable thyroid disease, or epilepsy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma
In Brief
A Phase 2 clinical trial evaluating Pamidronate, Thalidomide, and 1 other intervention for Multiple Myeloma. Completed, enrolled 83 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Patients will receive either pamidronate or zometa. Pamidronate is administered at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy.
All Patients will receive thalidomide 200 mg as an oral, once daily dose. Dose may be reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met. Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose)
Patients will receive either pamidronate or zometa. Zometa is administered at a dose of 4 mg by continuous infusion every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 4 mg every 4 weeks as maintenance therapy.