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.
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Eligibility:
– 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.
Design:
– 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.
Clinical Trial Conditions: Multiple Myeloma
Treatments in this Clinical Trial : Bortezomib, Lenalidomide, Dexamethasone
Clinical Trial Phase: Phase 2
Eligible Clinical Trial Participant Age : Between 18 years to 100 years
Can Healthy Volunteers Participate: No
Clinical Trial Lead Sponsor: National Cancer Institute (NCI)
Detailed Clinical Trial Description: 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.
-
Eligibility:
– 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.
Design:
– 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.
The clinical trial information was obtained from http://clinicaltrials.gov/ct2/show/NCT01647165
