Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring LENALIDOMIDE (CC-5013), BONE MARROW, 11-107
Eligibility Criteria
Inclusion Criteria:
- Patients must be 18 years of age or above at the time of enrollment.
- Patients must show evidence of asymptomatic relapse and/or progression of disease (increasing M spike in serum or urine by consensus criteria) while on lenalidomide maintenance after HDM/ASCT as part of initial line of therapy.
- Patients who have not had an HDM/ASCT as part of initial line of therapy but who are on continuous/maintenance lenalidomide after initial therapy will be permitted on study.
- Patient must have myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains. Measurable disease is defined as one or more of the following: serum M-protein ≥ to 0.5 g/dl, urine M-protein ≥ 200 mg/24 h, and/or serum FLC assay: involved FLC level > 10 mg/dL with abnormal serum FLC ratio.
- Patients must have adequate organ function including: Hepatic function with Bilirubin <2x the upper limit of normal and ALT and AST < 3 x the upper limit of normal; renal function with creatinine clearance ≥ 60 ml/min using the Cockcroft-Gault formula; hematologic function as defined by an absolute neutrophil count > 1000 neutrophils per microliter, platelet > 50,000 platelets per microliter and hemoglobin of ≥ 9 gm/dL without transfusion support
- All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
- Females of child bearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program
- FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
Exclusion Criteria:
- Patients with symptomatic relapse and/or progression of multiple myeloma. (Appendix A).
- Patients with plasma cell leukemia.
- Karnofsky performance score less than 70% or ECOG performance status greater than 2.
- Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
- Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ or other cancer treated with curative intent > 5 years previously. Cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Protocol Chairs.
- Female patients who are pregnant (positive HCG) or breastfeeding. (Lactating females must agree not to breast feed while taking lenalidomide)
- Patients seropositive for the human immunodeficiency virus (HIV).
- Prior organ transplant requiring immunosuppressive therapy.
- Patients who were previously exposed to higher doses of lenalidomide and who developed severe adverse events at higher doses that preclude incremental dosing.
Sites / Locations
- Stamford Hospital
- Memorial Sloan Kettering at Basking Ridge
- Memoral Sloan Kettering Cancer Center
- Montefiore Medical Center
- SUNY Downstate Medical Center
- North Shore LIJ
- Memorial Sloan Kettering Cancer Center
- Weill Cornell Medical Center
- University of Rochester Medical Center
- Memorial Sloan Kettering at Mercy Medical Center
- Memoral Sloan Kettering Cancer Center at Phelps
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lenalidomide
Arm Description
The proposed study is designed as a Phase II, multi-center trial of lenalidomide intensification in patients with asymptomatic POD while on low dose lenalidomide maintenance after HDM/ASCT or on continuous/maintenance therapy after initial treatment.
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary Outcome Measures
Number of Participants Evaluated for Toxicity
All toxicities with a maximum grade and status of ≥ grade 2 will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Full Information
NCT ID
NCT01463670
First Posted
October 28, 2011
Last Updated
April 12, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Montefiore Medical Center, State University of New York - Downstate Medical Center, University of Rochester, Weill Medical College of Cornell University, Stamford Hospital, Columbia University, State University of New York - Upstate Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01463670
Brief Title
Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance
Official Title
A Phase II Clinical Trial of Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 28, 2011 (Actual)
Primary Completion Date
March 19, 2021 (Actual)
Study Completion Date
March 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Montefiore Medical Center, State University of New York - Downstate Medical Center, University of Rochester, Weill Medical College of Cornell University, Stamford Hospital, Columbia University, State University of New York - Upstate Medical University
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether this disease will get better if treated with higher doses of Lenalidomide even if the disease returns while taking low doses of Lenalidomide. In patients with multiple myeloma treated with Lenalidomide maintenance, the disease will return. However, the physician currently does not know if the disease would respond to treatment with higher doses of Lenalidomide. This is very important for patients with multiple myeloma because the number of drugs available to treat the disease are limited. It is important to know if Lenalidomide remains still effective and if it can still be used in this situation. This study will try to find out what effects, good and/or bad higher doses of Lenalidomide has on the patient and the disease after it has returned.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
LENALIDOMIDE (CC-5013), BONE MARROW, 11-107
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lenalidomide
Arm Type
Experimental
Arm Description
The proposed study is designed as a Phase II, multi-center trial of lenalidomide intensification in patients with asymptomatic POD while on low dose lenalidomide maintenance after HDM/ASCT or on continuous/maintenance therapy after initial treatment.
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Intervention Description
patients will begin therapy with lenalidomide 25 mg daily, 21 days out of a 28 day schedule. All patients will be evaluated monthly after every cycle. The dose will be adjusted downward in response to side effects and according to specific guidelines. Symptomatic POD occurring at any time during the study will result in removal of the patient from the study. After 2 cycles of lenalidomide, patients with at least stable disease (SD) will continue lenalidomide indefinitely until asymptomatic POD, at which time dexamethasone will be added at a dose of 40mg weekly. On the other hand, patient with asymptomatic POD after 2 cycles of lenalidomide will have dexamethasone added at a dose of 40 mg weekly. Patients with any type of POD after any cycle that includes dexamethasone will be taken off study. Patients can remain on study on lenalidomide or lenalidomide/dexamethasone indefinitely as long as they do not have POD as stated above and they tolerate the treatment.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants Evaluated for Toxicity
Description
All toxicities with a maximum grade and status of ≥ grade 2 will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time Frame
every 28 days before initiation of a new cycle through study completion until disease progression up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be 18 years of age or above at the time of enrollment.
Patients must show evidence of asymptomatic relapse and/or progression of disease (increasing M spike in serum or urine by consensus criteria) while on lenalidomide maintenance after HDM/ASCT as part of initial line of therapy.
Patients who have not had an HDM/ASCT as part of initial line of therapy but who are on continuous/maintenance lenalidomide after initial therapy will be permitted on study.
Patient must have myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains. Measurable disease is defined as one or more of the following: serum M-protein ≥ to 0.5 g/dl, urine M-protein ≥ 200 mg/24 h, and/or serum FLC assay: involved FLC level > 10 mg/dL with abnormal serum FLC ratio.
Patients must have adequate organ function including: Hepatic function with Bilirubin <2x the upper limit of normal and ALT and AST < 3 x the upper limit of normal; renal function with creatinine clearance ≥ 60 ml/min using the Cockcroft-Gault formula; hematologic function as defined by an absolute neutrophil count > 1000 neutrophils per microliter, platelet > 50,000 platelets per microliter and hemoglobin of ≥ 9 gm/dL without transfusion support
All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
Females of child bearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program
FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
Exclusion Criteria:
Patients with symptomatic relapse and/or progression of multiple myeloma. (Appendix A).
Patients with plasma cell leukemia.
Karnofsky performance score less than 70% or ECOG performance status greater than 2.
Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ or other cancer treated with curative intent > 5 years previously. Cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Protocol Chairs.
Female patients who are pregnant (positive HCG) or breastfeeding. (Lactating females must agree not to breast feed while taking lenalidomide)
Patients seropositive for the human immunodeficiency virus (HIV).
Prior organ transplant requiring immunosuppressive therapy.
Patients who were previously exposed to higher doses of lenalidomide and who developed severe adverse events at higher doses that preclude incremental dosing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hani Hassoun, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Memorial Sloan Kettering at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memoral Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
North Shore LIJ
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
Country
United States
Facility Name
Memorial Sloan Kettering at Mercy Medical Center
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Memoral Sloan Kettering Cancer Center at Phelps
City
Sleepy Hollow
State/Province
New York
ZIP/Postal Code
10591
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance
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