- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463670
Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance
April 12, 2022 updated by: Memorial Sloan Kettering Cancer Center
A Phase II Clinical Trial of Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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Stamford, Connecticut, United States, 06902
- Stamford Hospital
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New Jersey
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Basking Ridge, New Jersey, United States
- Memoral Sloan Kettering Cancer Center
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering at Basking Ridge
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Brooklyn, New York, United States
- SUNY downstate Medical Center
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New Hyde Park, New York, United States, 11040
- North Shore LIJ
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10065
- Weill Cornell Medical Center
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Rochester, New York, United States
- University of Rochester Medical Center
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Rockville Centre, New York, United States
- Memorial Sloan Kettering at Mercy Medical Center
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Sleepy Hollow, New York, United States, 10591
- Memoral Sloan Kettering Cancer Center at Phelps
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: lenalidomide
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall Response Rate (ORR)
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants Evaluated for Toxicity
Time Frame: every 28 days before initiation of a new cycle through study completion until disease progression up to 5 years
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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.
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every 28 days before initiation of a new cycle through study completion until disease progression up to 5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Hani Hassoun, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 28, 2011
Primary Completion (Actual)
March 19, 2021
Study Completion (Actual)
March 19, 2021
Study Registration Dates
First Submitted
October 28, 2011
First Submitted That Met QC Criteria
October 28, 2011
First Posted (Estimate)
November 2, 2011
Study Record Updates
Last Update Posted (Actual)
May 6, 2022
Last Update Submitted That Met QC Criteria
April 12, 2022
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
Other Study ID Numbers
- 11-107
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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