Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide

NCT00083408 | Completed Phase 2

• 1 other identifier: UARK 99-016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate is in controlling multiple myeloma and to study any side effects that may be experienced.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Pamidronate; Thalidomide; refractory myeloma; bisphosphonates; Aredia

Outcome Measures

Primary Outcomes (1)

• To evaluate the effectiveness of combination treatment with Thalidomide and Pamidronate in patients with refractory myeloma and poor hematopoietic stem cell reserve. Effectiveness will be based on the estimate of the objective response rate (CR + PR).

Secondary Outcomes (1)

• To compare the effect of these agents on disease parameters, specifically on time to disease progression and overall survival.

Interventions

Pamidronate DRUG

Thalidomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a diagnosis of Multiple myeloma with poor hematopoietic reserve (platelet count \<100,000 OR inability to collect adequate PBSC to support autologous transplant (4X106 CD34+cells/kg OR WBC \<2,000)
• Patients must not be eligible for UARK 98-035
• Patients must be at least 6 weeks beyond previous chemotherapy
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences/MIRT

Little Rock, Arkansas, 72205, United States

Location

Related Links

• Myeloma Institute for Research \& Therapy website

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Pamidronate; Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Athanasios Fassas, M.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2004
• First Posted: May 25, 2004
• Study Start: March 1, 1998
• Study Completion: May 1, 2005
• Last Updated: July 5, 2010

Record last verified: 2010-07

Locations

US (1)