Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide - Tabular View

Tracking Information
First Received Date ^ICMJE	May 21, 2004
Last Updated Date	December 7, 2007
Start Date ^ICMJE	December 1998
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: December 7, 2007)	To evaluate the effectiveness of combination treatment with Thalidomide and Pamidronate in patients with smoldering or indolent myeloma. Effectiveness will be based on the estimate of the objective response rate (CR + PR). [ Time Frame: life time ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	To evaluate the effectiveness of combination treatment with Thalidomide and Pamidronate in patients with smoldering or indolent myeloma. Effectiveness will be based on the estimate of the objective response rate (CR + PR).
Change History	Complete list of historical versions of study NCT00083382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 7, 2007)	To compare the effect of these agents on disease parameters, specifically on time to disease progression and overall survival. [ Time Frame: life time ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	To compare the effect of these agents on disease parameters, specifically on time to disease progression and overall survival.

Descriptive Information
Brief Title ^ICMJE	Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
Official Title ^ICMJE	UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Multiple Myeloma
Intervention ^ICMJE	Drug: Pamidronate Drug: Thalidomide Drug: Zometa
Study Arms / Comparison Groups
Publications *	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. Epub 2008 Jul 31.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	July 2008
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00083382
Responsible Party	Naveen Kumar, CRA, University_of_Arkansas
Study ID Numbers ^ICMJE	UARK 98-036
Study Sponsor ^ICMJE	University of Arkansas
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	University of Arkansas
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP