Phase II Study of Subcutaneous (SC) Bortezomib, Lenalidomide and Dexamethasone for Relapsed and/or Refractory Multiple Myeloma; Followed by SC Bortezomib Maintenance
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|ClinicalTrials.gov Identifier: NCT01647165|
Recruitment Status : Withdrawn
First Posted : July 20, 2012
Last Update Posted : December 12, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Bortezomib Drug: Lenalidomide Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Subcutaneous (SC) Bortezomib, Lenalidomide and Dexamethasone for Relapsed and/or Refractory Multiple Myeloma; Followed by SC Bortezomib Maintenance|
|Study Start Date :||July 11, 2012|
|Estimated Primary Completion Date :||June 26, 2015|
|Estimated Study Completion Date :||June 26, 2015|
- Drug: Bortezomib
Cycle 1-8: 1.0 mg/m2 SC at a concentration of 2.5 mg/ml or 1 mg/ml to the thighs or abdomen on days 1, 4, 8, 11 of a 21 day cycle for 8 cycles.
- Drug: Lenalidomide
Cycle 1: 15 mg oral daily on days 2-14 of 21 day cycle; Cycle 2-8: 15 mg oral daily on days 1-14 of a 21 day cycle
- Drug: Dexamethasone
Cycle 1: 10 mg oral or IV daily on days 2,4,5,8,9,11,12 of a 21 day cycle; Cycle 2-8: 10 mg oral or IV on days 1, 2, 4, 5, 8, 9, 11, 12 of a 21 day cycle
- Overall Response Rate [ Time Frame: 2 years ]
- Progression-free survival [ Time Frame: 3 years ]
- Duration of response [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647165
|Principal Investigator:||Carl O Landgren, M.D.||National Cancer Institute (NCI)|