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| ID | Type | Description | Link |
|---|---|---|---|
| RV-MM-PrECOG-0394 | Other Identifier | Celgene Protocol |
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Slow enrollment
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| Name | Class |
|---|---|
| Celgene | INDUSTRY |
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Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will study how well the the treatment works in patients with previously treated (relapsed or refractory) multiple myeloma and kidney dysfunction.
Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more cancer cells. Lenalidomide and dexamethasone may have different effects in patients who have changes in their kidney function.
Multiple Myeloma (MM) affects approximately 20,000 Americans annually and remains an incurable hematologic malignancy characterized by frequent early response followed by universal treatment relapse necessitating multiple sequential therapeutic regimens. Until recently, few effective therapies existed. Several novel agents for MM have now become available including the immunomodulatory drugs thalidomide, lenalidomide, as well as the proteasome inhibitor, bortezomib. Each of these agents is undergoing extensive clinical evaluation in combination with other therapies to produce unprecedented response rates in newly diagnosed and relapsed MM. Lenalidomide has proven to be a highly effective treatment agent, particularly when used in combination with dexamethasone but is renally excreted and little information is available about its use in myeloma patients with impaired kidney function (20% have renal failure at some time after diagnosis). Defining a safe and effective dose of lenalidomide to use is a critical step in MM treatment.
OUTLINE: This is a Phase I, dose-escalation study of lenalidomide followed by a Phase II study. Patients are stratified according to degree of renal dysfunction (moderate [creatinine clearance 30-60 mL/min] vs severe [creatinine clearance <30 mL/min and does not require dialysis] vs end-stage renal disease [creatinine clearance <30 mL/min and requires dialysis]).
Patients receive oral lenalidomide on days 1-21 and low-dose oral dexamethasone 40 mg on days 1, 8, 15, and 22. There is a 7 day rest (days 22-28) from lenalidomide. Each cycle is 28 days and repeated in the absence of disease progression or unacceptable toxicity.
Patients enrolled in the phase II portion of the study will undergo blood sample collection periodically for pharmacokinetic analysis of lenalidomide (Mayo Clinic sites only).
After completion of study treatment, patients are followed every 6 months for up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - CrCl 30-60 mL/min | Experimental | Creatinine clearance 30 - 60 mL/min, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants. |
|
| Group B, CrCl < 30 mL/min | Experimental | Creatinine clearance < 30 mL/min, not on dialysis, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants. |
|
| Group C, CrCl < 30 mL/min, on dialysis | Experimental | Creatinine clearance < 30 mL/min and on dialysis, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | Given by mouth days 1-21 of a 28-day cycle. There is a 7 day rest (days 22-28). Continue until disease progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy | Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved:
| First cycle of therapy (28 days) |
| Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR] | Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, <5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to < 200 mg per 24 hours, >=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, >=50% reduction in bone marrow plasma cells, if baseline percentage was >=30%, >=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components | 56 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Time | Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive. | 56 months |
| Duration of Response |
Not provided
Inclusion Criteria:
Diagnosed with previously treated multiple myeloma.
Measurable disease assessed by one of the following ≤21 days prior to registration:
All previous cancer therapy including chemotherapy, radiation, hormonal therapy and surgery, must be discontinued ≥2 weeks prior to registration.
Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Acceptable organ and marrow function ≤21 days prior to registration:
Renal impairment at baseline as measured by serum creatinine clearance (CrCl) ≤60 mL/min ≤21 days prior to registration.
Females of Childbearing Potential (FCBP) must have a negative pregnancy test within 10-14 days and again within 24 hours of starting Cycle 1 and must use an effective double-method contraception for ≥28 days prior to, during, and for ≥28 days after completion of study therapy.
Able to take required prophylactic anticoagulation.
Able to understand and willingness to sign a written informed consent.
Willing to provide blood samples for research purposes (Mayo Clinic sites only).
If previously received lenalidomide, demonstration of clinical response of any duration or stable disease with progression-free interval of ≥6 months from start of that therapy.
Exclusion Criteria:
Concurrent use of other anti-cancer agents or treatments. Growth factors and bisphosphonates are allowed as medically indicated. Steroids may be used with an equivalency of up to 20 mg of Prednisone per day as long as the dose has not been adjusted upwards in past 2 weeks prior to study registration.
Uncontrolled intercurrent illness including, but not limited to, any of the following:
Any of the following as this regimen may be harmful to a developing fetus or nursing child:
HIV-positive patients on combination antiretroviral therapy.
Known hypersensitivity to thalidomide or other immunomodulatory drugs.
History of Stevens-Johnson syndrome characterized by a desquamating rash while taking thalidomide or similar drugs.
Other active malignancy except for non melanoma skin cancer or in situ cervical or breast cancer.
Concurrent radiation therapy, except for palliation of a single painful bone lesion or fracture.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph R. Mikhael, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259-5499 | United States | ||
| Emory University Winship Cancer |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30190454 | Result | Mikhael J, Manola J, Dueck AC, Hayman S, Oettel K, Kanate AS, Lonial S, Rajkumar SV. Lenalidomide and dexamethasone in patients with relapsed multiple myeloma and impaired renal function: PrE1003, a PrECOG study. Blood Cancer J. 2018 Aug 29;8(9):86. doi: 10.1038/s41408-018-0110-7. |
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Data is proprietary.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A Lenalidomide 10 mg/Day | Creatinine clearance (CrCl) of 30 - 60 mL/min. Lenalidomide 10 mg/day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose Level 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 28, 2011 | Jul 29, 2018 |
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|
| Dexamethasone | Drug | 40 mg given by mouth days 1, 8, 15 and 22 of a 28-day cycle. Continue until disease progression or unacceptable toxicity. |
|
|
| Anticoagulants | Drug | Anticoagulation consisted of aspirin at either 81 mg/day or 325 mg/day at the physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. |
|
|
Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attributed solely to the myeloma also constituted progression.
| 56 months |
| Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient | The highest degree of any adverse event experienced by each patient, as assessed by NCI CTCAE Version 4, with an attribution of possibly, probably, or definitely related to treatment. Reportable adverse events included those occurring while on treatment or within 30 days of the end of treatment. | 56 months |
| Renal Function Over Time | To describe renal function over time and to evaluate the safety profile of a onetime increase in lenalidomide dose at least 2 cycles after start of treatment due to improved renal function. | 56 months |
| Pharmacokinetics of Lenalidomide in Impaired Renal Function | To determine the pharmacokinetics of lenalidomide administration in myeloma patients with impaired renal function (pharmacokinetic analysis will be performed in up to 12 consented Mayo Clinic subjects treated during the Phase II component of the trial (only). | 56 months |
| Progression-free Survival | Progression-free survival is the time from registration to disease progression or death. Patients alive without disease progression were censored at the time of the last disease assessment. | 56 months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of IL at Chicago | Chicago | Illinois | 60612 | United States |
| McFarland Clinic | Ames | Iowa | 50010 | United States |
| Siouxland Hematology Oncology Associates | Sioux City | Iowa | 51101 | United States |
| Michigan Cancer Research Consortium and Oncology Research- St. Joseph Mercy Hospital - Ann Arbor | Ann Arbor | Michigan | 48106-0955 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Metro MN CCOP | Saint Louis Park | Minnesota | 55416 | United States |
| Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Kinston Medical Specialists | Kinston | North Carolina | 28501 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4283 | United States |
| Reading Hospital and Medical Center | West Reading | Pennsylvania | 19611 | United States |
| WVU Mary Babb Randolph Cancer Center | Morgantown | West Virginia | 26506 | United States |
| Gundersen Lutheran | La Crosse | Wisconsin | 54601 | United States |
| Waukesha Memorial Hospital (ProHealth Care) | Waukesha | Wisconsin | 53188 | United States |
| Aurora Cancer Center | Wauwatosa | Wisconsin | 53226 | United States |
| FG001 | Group A Lenalidomide 15 mg/Day | Creatinine clearance of 30 - 60 mL/min. Treated with lenalidomide 15 mg/day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. |
| FG002 | Group A Lenalidomide 25 mg/Day | Creatinine clearance of 30 - 60 mL/min. Treated with lenalidomide 25 mg/day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. |
| FG003 | Group B Lenalidomide 15 mg/2 Days | Creatinine clearance < 30 mL/min, not on dialysis. Treated with lenalidomide 15 mg/every other day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. |
| FG004 | Group B Lenalidomide 25 mg/2 Days | Creatinine clearance of <30 mL/min, not on dialysis. Treated with lenalidomide 25 mg every other day for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. |
| FG005 | Group B Lenalidomide 15 mg/Day | Creatinine clearance < 30 mL/min, not on dialysis. Treated with lenalidomide at 15 mg/day for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. |
| FG006 | Group B Lenalidomide 25 mg/Day | Creatinine clearance < 30 mL/min, not on dialysis. Treated with lenalidomide at 25 mg/day for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. |
| FG007 | Group C Lenalidomide 15 mg 3x/Week | Creatinine clearance of 30 - 60 mL/min and on dialysis. Treated with lenalidomide 15 mg 3 days/week for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis. |
| FG008 | Group C Lenalidomide 10 mg/Day | Creatinine Clearance < 30 mL/min and on dialysis, treated with lenalidomide 15 mg 3 times per week, dexamethasone and anticoagulant |
| FG009 | Group C Lenalidomide 15 mg/Day | Creatinine Clearance < 30 mL/min and on dialysis, treated with lenalidomide 10 mg/day, dexamethasone, and anticoagulants |
| FG010 | Group C, Lenalidomide 25 mg/Day | Creatinine clearance < 30 mL/min and on dialysis, treated with lenalidomide at 25 mg/day, dexamethasone, and anticoagulants |
| Began Treatment |
|
| COMPLETED | Treated until disease progression |
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| NOT COMPLETED |
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| Dose Level 2 |
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| Dose Level 3 |
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| Dose Level 4 |
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| Expansion Cohort |
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|
Eligible, treated patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A=30-60 CrCl (mL/Min) | Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. |
| BG001 | Group B=CrCL<30 mL/Min Not on Dialysis | Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group B=CrCL<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. |
| BG002 | Group C=CrCL<30 mL/Min and on Dialysis | Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Creatinine Clearance | Serum creatinine clearance, mL/minute | Median | Inter-Quartile Range | mL/min |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy | Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved:
| Patients treated during the dose finding phase of the study | Posted | Count of Participants | Participants | First cycle of therapy (28 days) |
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| Primary | Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR] | Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, <5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to < 200 mg per 24 hours, >=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, >=50% reduction in bone marrow plasma cells, if baseline percentage was >=30%, >=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components | Patients treated at the recommended phase II dose | Posted | Number | 90% Confidence Interval | percentage of participants | 56 months |
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| Secondary | Overall Survival Time | Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive. | Eligible, treated patients | Posted | Median | 90% Confidence Interval | months | 56 months |
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| Secondary | Duration of Response | Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attributed solely to the myeloma also constituted progression. | Patients treated at the recommended phase II dose who experienced a response to treatment | Posted | Median | Inter-Quartile Range | Months | 56 months |
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| Secondary | Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient | The highest degree of any adverse event experienced by each patient, as assessed by NCI CTCAE Version 4, with an attribution of possibly, probably, or definitely related to treatment. Reportable adverse events included those occurring while on treatment or within 30 days of the end of treatment. | All patients who started treatment | Posted | Number | participants | 56 months |
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| Secondary | Renal Function Over Time | To describe renal function over time and to evaluate the safety profile of a onetime increase in lenalidomide dose at least 2 cycles after start of treatment due to improved renal function. | This outcome was not analyzed because the dose increase was not implemented. | Posted | 56 months |
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| Secondary | Pharmacokinetics of Lenalidomide in Impaired Renal Function | To determine the pharmacokinetics of lenalidomide administration in myeloma patients with impaired renal function (pharmacokinetic analysis will be performed in up to 12 consented Mayo Clinic subjects treated during the Phase II component of the trial (only). | As only 1 patient was enrolled from Mayo Clinic during the Phase II component of the study, samples were neither collected nor analyzed for this endpoint. | Posted | 56 months |
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| Secondary | Progression-free Survival | Progression-free survival is the time from registration to disease progression or death. Patients alive without disease progression were censored at the time of the last disease assessment. | Patients treated at the recommended phase II dose | Posted | Median | 90% Confidence Interval | Months | 56 months |
|
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A Lenalidomide 10 mg/Day | CrCl 30-60 mL/min. Lenalidomide 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. | 1 | 6 | 5 | 6 | 5 | 6 |
| EG001 | Group A Lenalidomide 15 mg/Day | CrCl 30-60 mL/min. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. | 1 | 3 | 2 | 3 | 2 | 3 |
| EG002 | Group A Lenalidomide 25 mg/Day | CrCl 30-60 mL/min. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. | 0 | 6 | 5 | 6 | 6 | 6 |
| EG003 | Group A Expansion Cohort | CrCl 30-60 mL/min. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose. | 4 | 14 | 10 | 14 | 14 | 14 |
| EG004 | Group B Lenalidomide 15 mg/2 Days | CrCl <30 mL/min, not on dialysis. Lenalidomide 15 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. | 0 | 3 | 3 | 3 | 1 | 3 |
| EG005 | Group B Lenalidomide 25 mg/2 Days | CrCl <30 mL/min, not on dialysis. Lenalidomide 25 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. | 0 | 3 | 3 | 3 | 3 | 3 |
| EG006 | Group B Lenalidomide 15 mg/Day | CrCl <30 mL/min, not on dialysis. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG007 | Group B Lenalidomide 25 mg/Day | CrCl <30 mL/min, not on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. | 0 | 8 | 5 | 8 | 8 | 8 |
| EG008 | Group B Expansion Cohort | CrCl <30 mL/min, not on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose. | 0 | 2 | 1 | 2 | 2 | 2 |
| EG009 | Group C Lenalidomide 15 mg 3x/wk | CrCl < 30 mL/min, on dialysis. Lenalidomide 15 mg three times weekly for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. | 0 | 3 | 2 | 3 | 1 | 3 |
| EG010 | Group C Lenalidomide 10 mg/Day | CrCl < 30 mL/min, on dialysis. Lenalidomide 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. | 1 | 3 | 3 | 3 | 2 | 3 |
| EG011 | Group C Lenalidomide 15 mg/Day | CrCl < 30 mL/min, on dialysis. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. | 1 | 3 | 3 | 3 | 3 | 3 |
| EG012 | Group C Lenalidomide 25 mg/Day | CrCl < 30 mL/min, on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. | 0 | 5 | 4 | 5 | 4 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other (Eosinophilia) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other (Pancytopenia) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other (Thrombocytopenia) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Heart Failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Middle ear inflammation | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vitreous hemorrhage | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastric hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Intra-abdominal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other (Diverticulitis) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other (Hepatic cirrhosis) | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other (Hepatobiliary disease) | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Other (Cellulitis) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Other (Clostridial infection) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Other (Localized infection) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| INR increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other (pulmonary mass) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other (post-traumatic pain) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other (Uremic encephalopathy) | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral ischemia | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic Event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Other (Laceration) | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other (Muscle spasms) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PrECOG Statistician | PrECOG | 978-835-3516 | jbmanola@gmail.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 26, 2017 | Jul 29, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D000925 | Anticoagulants |
| D001241 | Aspirin |
| D006493 | Heparin |
| D006495 | Heparin, Low-Molecular-Weight |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
Not provided
Not provided
| Physician Decision |
|
| Withdrawal by Subject |
|
| Intercurrent Illness/Other Treatment |
|
| Withdrawal by Subject |
|
| Intercurrent Illness/Alternative Therapy |
|
| Ineligible/Withdrew before Treatment |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Death |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Study Closure |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Recommended phase 2 dose for patients in Group B |
| Dose in milligrams/day |
| 25 |
| 2-Sided |
Because no dose limiting toxicities were noted, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance < 30 mL/minute who are not on dialysis |
| Other |
Recommended phase 2 dose for patients in Group B |
| Recommended phase 2 dose for Group C | Lenalidomide dose in mg/day | 25 | 2-Sided | Because no dose limiting toxicities were observed, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance < 30 mL/min who are receiving dialysis | Other | Recommended phase 2 dose for Group C |
| OG002 | Group C CrCL<30 mL/Min and on Dialysis | Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. |
|
|
| Group C=CrCL<30 mL/Min and on Dialysis |
Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis. |
|
|
|
|
CrCl 30-60 mL/min, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.
| OG004 | Group B Lenalidomide 15 mg/2 Days | CrCl < 30 mL/min, not on dialysis. Lenalidomide days 15 mg every 2 days from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. |
| OG005 | Group B Lenalidomide 25 mg/2 Days | CrCl < 30 mL/min, not on dialysis. Lenalidomide 25 mg every 2 days from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. |
| OG006 | Group B Lenalidomide 15 mg/Day | CrCl < 30 mL/min, not on dialysis. Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. |
| OG007 | Group B Lenalidomide 25 mg/Day | CrCl < 30 mL/min, not on dialysis. Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. |
| OG008 | Group B Expansion Cohort | CrCl < 30 mL/min, not on dialysis. Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose. |
| OG009 | Group C Lenalidomide 15 mg 3x/Week | CrCl < 30 mL/min, on dialysis, Lenalidomide 15 mg 3 times a week from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. |
| OG010 | Group C Lenalidomide 10 mg/Day | CrCl < 30 mL/min, on dialysis, Lenalidomide 10 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. |
| OG011 | Group C Lenalidomide 15 mg/Day | CrCl < 30 mL/min, on dialysis, Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. |
| OG012 | Group C Lenalidomide 25 mg/Day | CrCl < 30 mL/min, on dialysis, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. |
|
|
| OG002 |
| Group C=CrCL<30 mL/Min and on Dialysis |
Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis. |
|
| OG002 | Group C=CrCL<30 mL/Min and on Dialysis | Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis. |
|
| OG002 | Group C=CrCL<30 mL/Min and on Dialysis | Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis. |
|
|