Phase II Study of Subcutaneous (SC) Bortezomib, Lenalidomide and Dexamethasone for Relapsed and/or Refractory Multiple Myeloma; Followed by SC Bortezomib Maintenance
Background: Bortezomib is a drug approved by the Food and Drug Administration (FDA) to treat patients with multiple myeloma. It is given by intravenous injection. Lenalidomide is a drug that alters the immune system. It may also help suppress tumor growth. It is approved by the FDA to treat some types of blood cancers. Dexamethasone prevents or treats inflammation. It is sometimes used to treat multiple myeloma.
Objectives: The purpose of this study examine how the combination of the study drugs affects myeloma.
- Participants at least 18 years old who have multiple myeloma that has come back, did not respond to treatment, or worsened while being treated.
- Participants who may be pregnant will be tested to ensure that they are not pregnant.
- Participants will be screened with a history and physical examination. Blood work and urine samples will be taken. A series of x-rays of all bones will be done. A bone marrow biopsy will be done.
- Treatment will be monitored with frequent blood tests and imaging studies.
- Treatment will continue as long as the cancer does not grow or spread and no serious side effects develop.
- There will be up to eight 21-day treatment cycles.
- Bortezomib is given by subcutaneous (under the skin) (SC) injection on days 1, 4, 8, and 11 of the cycle.
- Lenalidomide is given by mouth on days 1-14 of the cycle.
- Dexamethasone is given by mouth on days 1, 2, 4, 5, 8, 9, 11, and 12 of the cycle.
- Following cycle eight, if the disease is stable or better, participants will receive bortezomib SC at the dose given at the end of cycle eight.
- Participants will take valacyclovir or acyclovir while taking bortezomib to prevent virus infections.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Subcutaneous (SC) Bortezomib, Lenalidomide and Dexamethasone for Relapsed and/or Refractory Multiple Myeloma; Followed by SC Bortezomib Maintenance|
- Overall Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
|Contact: Marcia Mulquin, R.N.||(301) firstname.lastname@example.org|
|Contact: Carl O Landgren, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Not yet recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Carl O Landgren, M.D.||National Cancer Institute (NCI)|