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Multiple Myeloma

Elotuzumab + Bortezomib for Multiple Myeloma Following One to Three Prior Therapies (2224)
A Phase 1 / 2, Multi-Center, Open-Label, Dose-Escalation Study of Elotuzumab (Humanized anti-CS1 Monoclonal IgG1 antibody) and Bortezomib in Subjects with Multiple Myeloma Following One to Three Prior Therapies
Status Conditions Phase Study ID
Closed Multiple Myeloma (MM) Phase I/II 2224
NCT00726869
Summary

The purpose of this study is to test an experimental drug called elotuzumab given with the drug bortezomib. (Bortezomib is approved by the FDA for multiple myeloma treatment; it is also called Velcade®). We want to know whether or not the combination of these drugs is safe and to see what effects, good or bad, it has on multiple myeloma in patients who have been previously treated with one to three other therapies.

In this study, we want to learn:

• the best way to give elotuzumab with bortezomib

• how much elotuzumab with bortezomib can be given safely

We will start by giving low amounts of the study drug (elotuzumab) with bortezomib to the first study participants. The dose of bortezomib will remain at the standard dose for all participants throughout the study. We will increase the amount of elotuzumab for later participants until side effects (good or bad) appear.

Treatment in the study will last about 3 months. During this time, participants will have regularly scheduled visits to the outpatient clinic at the Seattle Cancer Care Alliance (SCCA). If the disease responds or stabilizes after the first 3 months of treatment on the study, study participants will then be allowed to continue receiving elotuzumab and bortezomib (and dexamathasone if the doctor decides that it is needed) for 2 ½ more months or longer.

After the last dose of the study drug is taken, study participants will come to the SCCA outpatient clinic for two follow-up visits: the first within a week and the second at 30 days.


Investigator
Bill Bensinger, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

1. Age 18 years or older

 

2. Diagnosis of multiple myeloma (MM) with 1 to 3 relapses

 

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

1. Prior malignancy

 

2. Severe neuropathy

 

3. Current orthostatic hypotension (low blood pressure that happens upon standing)

 

4. Known active infections requiring antibiotic, antiviral or antifungal therapy

 

5. Current radiation treatment

 

Other exclusion criteria may apply.

Last Updated
July 19, 2010
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.