Last updated: January 5, 2021
Sponsor: Boston VA Research Institute, Inc.
Overall Status: Completed
Phase
2
Condition
Cancer
Cancer/tumors
Leukemia
Treatment
N/AClinical Study ID
NCT01380106
RV-MM-PI-0345
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Previously diagnosed with multiple myeloma.
- Must have relapsed or refractory disease (refractory is defined as progression duringtreatment or within 60 days after the completion of treatment) requiring 2nd or 3rdline therapy
- Patients may have received lenalidomide and/or dexamethasone
- Patients must have measurable disease:
- Serum monoclonal protein >0.5g/dL and/or 0.2g/24hr urine light chain excretion
- Patients with lower M-protein values or non-secretory myeloma will be eligible ifmeasurable disease can be established, such as serum FreeliteTM chain ratio >5xULN, measurable soft tissue plasmacytoma >2cm by either physical exam and/orapplicable radiographs (i.e. MRI, CT-scan) and/or bone marrow involvement >30%
- Age >=18 years at the time of consent.
- All necessary baseline studies for determining eligibility must be obtained within 14days prior to enrollment. Serum pregnancy tests (sensitivity of at least 25 mIU/mL),for females of childbearing potential (WCBP) must be completed. The first test must beperformed within 10-14 days, and the second test within 24 hours prior to initiationof lenalidomide.
- Pre-study ECOG performance status 0-2. Patients with lower performance status basedsolely on bone pain will be eligible.
- Adequate liver functions: AST and ALT =< 3xULN, alkaline phosphatase =< 3.0x ULN,except if attributed to tumor, and bilirubin =< 2xULN.
- Have Amylase =< 2.5x ULN
- Able to adhere to the study visit schedule and other protocol requirements
- Must understand and voluntarily sign an informed consent document.
- Females of childbearing potential (FCBP)† must have a negative serum or urinepregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to andagain within 24 hours of starting lenalidomide and must either commit to continuedabstinence from heterosexual intercourse or begin TWO acceptable methods of birthcontrol, one highly effective method and one additional effective method AT THE SAMETIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree toongoing pregnancy testing. Men must agree not to father a child and agree to use acondom if his partner is of child bearing potential. All patients must be counseled ata minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- All study participants must be registered into the mandatory RevAssist® program, andbe willing and able to comply with the requirements of RevAssist®. All counseling willbe done through RevAssist®.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. Patientsintolerant to ASA may use low molecular weight heparin. Lovenox is recommended.Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.
- Patients may receive a bisphosphonate.
Exclusion
Exclusion Criteria:
- Any serious medical condition, laboratory abnormality, or psychiatric illness thatwould prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females.(Lactating females must agree not to breast feedwhile taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places thesubject at unacceptable risk if he/she were to participate in the study or confoundsthe ability to interpret data from the study.
- Renal insufficiency of creatinine clearance <40mL/min
- Known hypersensitivity to thalidomide or lenalidomide.
- Development of erythema nodosum if characterized by a desquamating rash while takingthalidomide or similar drugs.
- Concurrent use of other anti-cancer agents or treatments.
- Known seropositive for an active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who areseropositive because of hepatitis B virus vaccine are eligible.
- Has hemoglobin <8.0g/dL. The use of transfusion with pRBC to correct anemia and meeteligibility criteria will not be allowed.
- Has an absolute neutrophil count <1.0x10^9/L within 14 days before enrollment
- Peripheral neuropathy of grade >=3. Patients with painful grade 2 neuropathy are alsoexcluded
- Has platelet count <75x10^9/L within 14 days before enrollment.
- Plasma cell leukemia at time of study entry.
Study Design
Total Participants: 33
Study Start date:
August 01, 2010
Estimated Completion Date:
September 11, 2017
Study Description
Connect with a study center
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas 72205
United StatesSite Not Available
West Los Angeles VA Medical Center
Los Angeles, California 90073
United StatesSite Not Available
Edward Hines Jr VA Hospital
Hines, Illinois 60141
United StatesSite Not Available
VA Boston Healthcare System
Jamaica Plain, Massachusetts 02130
United StatesSite Not Available
Kansas City VA Medical Center
Kansas City, Missouri 64128
United StatesSite Not Available
Pittsburgh VA Medical Center
Pittsburgh, Pennsylvania 15240
United StatesSite Not Available
Houston VA Medical Center
Houston, Texas 77030
United StatesSite Not Available

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