Phase 2
Completed N=83
Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
Source: ClinicalTrials.gov NCT00083382 ↗Enrolled (actual)
83
Serious AEs
19.3%
Results posted
Jun 2015
Primary outcomePrimary: Best Response — 56; 17; 10 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Response |
56; 17; 10 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00083382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.