- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00083382
Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences/MIRT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Thalidomide + Bisphosphonate
200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best Response
Time Frame: 2 years
|
Best response to study treatment as defined by protocol-specific response criteria: Complete Response (CR) = absence of urine and serum M-components by immunofixation; bone marrow should be adequately cellular (>20%) with <1% monoclonal plasma cells by DNA-clg flow cytometry; serum calcium level must be normal; no new bone lesions nor enlargement of existing lesions; Normalization of serum concentrations of normal immunoglobulins is not required for CR. Partial Response (PR) = Reduction by > 75% in serum myeloma protein production; Decrease in monoclonal marrow plasmacytosis to <5%; Decrease in Bence-Jones proteinuria by >90%; No new lytic bone lesions or soft tissue plasmacytoma. Treatment Failures/Progressive Disease (PD) = Such patients do not fulfill the above criteria and/or have new lytic lesions (but not compression fractures), hypercalcemia, or other new manifestations of disease. |
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Bone Density Conservation Agents
- Thalidomide
- Pamidronate
Other Study ID Numbers
- UARK 98-036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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