Back to resultsCombination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pamidronate
Thalidomide
Zometa
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, Thalidomide, Pamidronate, Aredia, Bisphosphonate, Anti-Angiogenesis, Smoldering/Indolent Myeloma, Zometa
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.
Sites / Locations
- University of Arkansas for Medical Sciences/MIRT
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thalidomide + Bisphosphonate
Arm Description
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
Outcomes
Primary Outcome Measures
Best Response
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00083382
Brief Title
Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Recently laboratory research found that thalidomide can inhibit the formation of new blood vessels that are necessary for the growth and spread of cancer. In order to grow and increase in size tumors require new blood vessels to supply them with the necessary blood to grow. If we can prevent these new blood vessels feeding the tumor from being formed by using thalidomide we might slow or stop the growth of the tumor. This concept is called "anti-angiogenesis" It is hoped that thalidomide will slow or stop the growth myeloma. However, it cannot be guaranteed that you will benefit if you take part in this study. The treatment you receive may even be harmful.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Myeloma, Thalidomide, Pamidronate, Aredia, Bisphosphonate, Anti-Angiogenesis, Smoldering/Indolent Myeloma, Zometa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thalidomide + Bisphosphonate
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Pamidronate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Zometa
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best Response
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Barlogie, MD, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences/MIRT
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18669874
Citation
Barlogie B, van Rhee F, Shaughnessy JD Jr, Epstein J, Yaccoby S, Pineda-Roman M, Hollmig K, Alsayed Y, Hoering A, Szymonifka J, Anaissie E, Petty N, Kumar NS, Srivastava G, Jenkins B, Crowley J, Zeldis JB. Seven-year median time to progression with thalidomide for smoldering myeloma: partial response identifies subset requiring earlier salvage therapy for symptomatic disease. Blood. 2008 Oct 15;112(8):3122-5. doi: 10.1182/blood-2008-06-164228. Epub 2008 Jul 31.
Results Reference
derived
Links:
URL
http://myeloma.uams.edu
Description
Myeloma Institute for Research & Therapy
Learn more about this trial
Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
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