Myelodysplastic Syndrome Study
Principal Investigator: R. Vinod Parameswaran , MD
Sub-Investigators: Kelly McCaul, MD; Addison Tolentino, MD; Mark Huber, MD; Amy Krie, MD; Michael Robinson, MD; Stephen Medlin, DO; Tammie Smart, CNP; Kristen Hurley, CNP
Study Coordinator: Erika Meyer, RN
Study Description: Phase I Combination Trial of SGN-33 (anti-huCD33 mAb; HuM195; lintuzumab) and Lenalidomide (Revlimid®) in Patients with Myelodysplastic Syndrome
Overview: The purpose of this research study is to evaluate the use of an investigational medication in combination with Revlimid (lenalidomide)in treating patients with Myelodysplastic Syndromes (MDS). This investigational medication is not a chemotherapy drug. Instead, it is a type of antibody believed to attach to a target on certain cancer cells, identifying the cancer cells as foreign. This may start a process that destroys the cell.
Participation in this study will last up to 10 months, including 8 cycles of treatment. Tests and procedures used solely for the purposes of research will be provided at no cost. Study drugs will also be provided at no cost.
Inclusion Criteria:
- Men and women, age 18 and older
- Have clinical diagnosis of MDS
- Have failed, been ineligible for, did not tolerate, or refused treatment with other approved therapies for MDS (other than lenalidomide for patients with chromosome 5 deletion)
Exclusion Criteria:
- Women who are pregnant, breastfeeding or planning to become pregnant
- Received any prior therapy with lenalidomide, Mylotarg® (gemtuzumab ozogamicin) or other anti-CD33 monoclonal antibody treatment
- Have known chronic viral infection with hepatitis B or C or HIV
Contact: Erika Meyer, RN
Phone: (605) 322-3086
Email: Erika.meyer@avera.org
