Lenalidomide Maintenance Therapy for Multiple Myeloma
Study Details
Study Description
Brief Summary
Background:
-
Multiple myeloma is rarely curable, but it is treatable. Initial treatment is directed at controlling symptoms and reducing the number of myeloma cells. It continues until the cancer stops responding to treatment. At that time, treatment may switch to maintenance therapy, which is given to try to extend the response of the first therapy for as long as possible. Research suggests that lenalidomide maintenance therapy may delay the time for myeloma cells to start to grow and possibly improve survival.
-
Lenalidomide is a drug that may reduce or prevent the growth of cancer cells. Researchers want to look at the long-term effect of lenalidomide on immune cells. It will also look at the effects of extended treatment on the cancer and the immune system.
Objectives:
- To test the long-term effectiveness of lenalidomide therapy for multiple myeloma.
Eligibility:
- Individuals at least 18 years of age with newly diagnosed or relapsed multiple myeloma.
Design:
-
Participants will be screened with a physical exam and medical history. Blood and urine sample will be collected. A bone scan and bone marrow biopsy will also be performed.
-
Participants will receive lenalidomide maintenance treatment. It will be given according to the standard of care for multiple myeloma. Participants will take lenalidomide every day for 21 days of repeated 28-day cycles.
-
Treatment will be monitored with frequent blood tests. Blood tests will look at the effect of the treatment on the immune system.
-
Treatment will continue as long as the cancer does not worsen and the side effects are not severe.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Background:
Multiple myeloma (MM) remains largely an incurable disease with an estimated median survival of 6-7 years in standard risk myeloma and 2-3 years in high risk disease despite treatment with autologous stem cell transplantation (ASCT).
Maintenance therapy to achieve sustained suppression of residual disease following chemotherapy or ASCT has long been viewed as a desirable approach for extending survival in MM.
Giving the immunomodulatory drug lenalidomide after induction or re-induction treatment may stimulate the immune system in various ways to stop or slow the return of cancer.
It is not yet known how immune stimulatory effects of extended dosing with lenalidomide in the maintenance setting correlate with clinical benefits.
Objectives:
Assess T cell (cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), natural killer T cell (NKT) and normal killer (NK) cell numbers in peripheral blood during the
course of lenalidomide maintenance therapy in treated MM patients.
Eligibility:
Patients with multiple myeloma who have achieved stable disease or better response, assessed at greater than or equal to 4 weeks after completing induction or re-induction treatment
Age greater than or equal to 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
Adequate hematological parameters defined by: absolute neutrophil count greater than or equal to 1.0 K/microL, hemoglobin greater than or equal to 8 g/dL, and platelet count greater than or equal to 75 K/microL
Adequate hepatic function, with bilirubin < 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times ULN
Adequate renal function with creatinine clearance (CrCl) of greater than or equal to 40 mL/min. CrCl will be calculated using the Cockcroft-Gault method. If the calculated CrCl based on Cockcroft-Gault method is <40 mL/min, patient will have a 24 hr urine collection to measure CrCl. The measured CrCl must also be greater than or equal to 40 ml/min
Design:
Single arm, single stage, phase II trial of lenalidomide maintenance for treated MM patients who have stable or responsive disease.
After screening, eligibility determination, and enrollment; subjects will receive lenalidomide 10 mg by mouth daily on days 1-21 of repeated 28-day cycles. When necessary, lenalidomide will be held and restarted in accordance with accepted clinical dose modification guidelines.
Subjects may continue lenalidomide until disease progression or unacceptable toxicity or completion of two years of lenalidomide therapy and the 30 day safety follow-up visit.
Blood will be obtained to assess changes in T cell (CD4, CD8), NKT and NK cell numbers by flow-cytometric analysis at pre-specified time points during lenalidomide maintenance.
Blood samples and/or bone marrow samples where possible, will be used for additional research studies, which may include functional analyses of immune-cell subsets, analyses for cytokines, chemokines, antibodies, tumor cell antigen targets, and/or other markers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lenalidomide Maintenance Therapy for Multiple Myeloma 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. |
Drug: Lenalidomide
10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
|
Outcome Measures
Primary Outcome Measures
- Longitudinal Assessment of T Cell (Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Natural Killer T-cell (NKT) and Natural Killer (NK) Cell Counts [participants were followed for the duration of their treatment, an average of 2 years]
Peripheral blood samples will be collected to assess T cell (CD4, CD8), NKT and NK cell counts using flow cytometry.
Secondary Outcome Measures
- Number of Participants With Serious and Non-serious Adverse Events [37 months and 12 days]
Here is the number of serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
- Duration of Response [participants were followed for the duration of their treatment, an average of 2 years]
Duration of response is defined as time from response to disease progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be >10mg/dl.
- Progression Free Survival (PFS) [participants were followed for the duration of their treatment, an average of 2 years]
PFS is defined as the time from study entry until progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be >10mg/dl.
- Natural Killer (NK) Cell Function and Activity [participants were followed for the duration of their treatment, an average of 2 years]
Percent of target cell lysis by NK cells
- Changes in B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy [participants were followed for the duration of their treatment, an average of 2 years]
Percent change in total number of B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy
- Expression of Cereblon (CRBN) and How it Relates to Natural Killer (NK) Cell Number and Activity [participants were followed for the duration of their treatment, an average of 2 years]
Relative fold change in CRBN and correlation (R2) to NK cell number and activity.
Eligibility Criteria
Criteria
-
INCLUSION CRITERIA:
-
Patients with multiple myeloma treated with induction therapy or re-induction therapy, who at the time of study enrollment have documented evidence of stable disease response or better according to International Myeloma Workshop Consensus Panel. The response assessment must occur at least 4 weeks after completion of their last treatment.
-
Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of lenalidomide in patients
-
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
-
Patient must have adequate hematologic, renal, hepatic, and cardiac function as defined by:
-
Absolute neutrophil count greater than or equal to 1.0 K/microL independent of growth factor support
-
Platelets greater than or equal to 75K/microL
-
Hemoglobin greater than or equal to 8 g/dL (transfusions are permissible)
-
Calculated creatinine (CrCl) clearance of greater than or equal to 40 mL/min. using the Cockcroft-Gault method. If the calculated CrCl based on Cockcroft-Gault method is
-
Total bilirubin less than or equal to 1.5 mg/dL, aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/ serum glutamic-pyruvic transaminase (SGPT) less than or equal to 3 times ULN
-
Females of childbearing potential (FCBP) must agree to use two effective forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of effective contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
-
A FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
-
A FCBP must have two negative serum or urine pregnancy tests prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to prescribing the study drug. The prescriptions of study drug must be filled within 7 days.
-
Male patients must agree to use a latex condom during sexual contact with FCBP while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
-
Patient must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to acetylsalicylic acid (ASA) may use warfarin or low molecular weight heparin.
-
Patient must understand and voluntarily sign an informed consent form, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.
EXCLUSION CRITERIA:
-
Patients with progressive or refractory multiple myeloma (MM), as defined by International Myeloma Workshop Consensus Panel criteria.
-
Refractory to lenalidomide in the most recent line of therapy, as defined by the International Myeloma Consensus Panel criteria - as failure to achieve minimal response or development of progressive disease while on lenalidomide or within 30 days of lenalidomide therapy
-
Patients who are receiving any other investigational agents with the intent to treat myeloma. Permitted concurrent therapies include:
-
Bisphosphonates
-
Radiotherapy to single stable disease site
-
Plasma cell leukemia
-
Pregnant or lactating females. Because there is a potential risk for adverse events to nursing infants secondary to treatment of the mother with lenalidomide, lactating females must agree not to breast feed while taking lenalidomide.
-
Uncontrolled hypertension or diabetes
-
Active hepatitis B or C infection
-
Diagnosed or treated for another malignancy within 3 years prior to study enrollment, with the exception of complete resection of non-melanoma skin cancer, or an in situ malignancy
-
Previous diagnosis of another malignancy with any evidence of residual disease.
-
Patients seropositive for the human immunodeficiency virus (HIV), and/or those who are taking anti-retroviral treatment for HIV/acquired immune deficiency syndrome (AIDS)
-
Prior organ transplant requiring immunosuppressive therapy
-
Prior allogeneic stem cell transplant
-
Patients requiring continuous, systemic immunosuppressive therapy
-
Patients with myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled cardiac arrhythmias, or electrocardiographic evidence of acute ischemia
-
Patients with conditions that would prevent absorption of the study drug
-
Uncontrolled intercurrent illness including but not limited to uncontrolled infection or psychiatric illness/social situations that would compromise compliance with study requirements
-
Significant neuropathy greater than or equal to Grade 3 at baseline
-
Contraindication to concomitant anticoagulation prophylaxis
-
Major surgery within 1 month prior to enrollment
-
Patients who were previously exposed and who developed severe adverse events, hypersensitivity or desquamating rash to either thalidomide or lenalidomide
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
- Celgene Corporation
Investigators
- Principal Investigator: Dickran Kazandijicn, M.D., National Cancer Institute (NCI)
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- Kyle RA, Rajkumar SV. Multiple myeloma. N Engl J Med. 2004 Oct 28;351(18):1860-73. Review. Erratum in: N Engl J Med. 2005 Mar 17;352(11):1163.
- Landgren O, Kyle RA, Pfeiffer RM, Katzmann JA, Caporaso NE, Hayes RB, Dispenzieri A, Kumar S, Clark RJ, Baris D, Hoover R, Rajkumar SV. Monoclonal gammopathy of undetermined significance (MGUS) consistently precedes multiple myeloma: a prospective study. Blood. 2009 May 28;113(22):5412-7. doi: 10.1182/blood-2008-12-194241. Epub 2009 Jan 29.
- Rajkumar SV, Kyle RA. Multiple myeloma: diagnosis and treatment. Mayo Clin Proc. 2005 Oct;80(10):1371-82. Review.
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Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Lenalidomide Maintenance Therapy for Multiple Myeloma |
|---|---|
| Arm/Group Description | 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. |
| Period Title: Overall Study | |
| STARTED | 11 |
| COMPLETED | 0 |
| NOT COMPLETED | 11 |
Baseline Characteristics
| Arm/Group Title | Lenalidomide Maintenance Therapy for Multiple Myeloma |
|---|---|
| Arm/Group Description | 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. |
| Overall Participants | 11 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
9
81.8%
|
| >=65 years |
2
18.2%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
57.05
(8.28)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
36.4%
|
| Male |
7
63.6%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
2
18.2%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
2
18.2%
|
| White |
5
45.5%
|
| More than one race |
1
9.1%
|
| Unknown or Not Reported |
1
9.1%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Not Hispanic |
9
81.8%
|
| Mexican, Cuban, Puerto Rican, Central/So. American |
2
18.2%
|
| Region of Enrollment (participants) [Number] | |
| United States |
11
100%
|
Outcome Measures
| Title | Longitudinal Assessment of T Cell (Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Natural Killer T-cell (NKT) and Natural Killer (NK) Cell Counts |
|---|---|
| Description | Peripheral blood samples will be collected to assess T cell (CD4, CD8), NKT and NK cell counts using flow cytometry. |
| Time Frame | participants were followed for the duration of their treatment, an average of 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions. |
| Arm/Group Title | Lenalidomide Maintenance Therapy for Multiple Myeloma |
|---|---|
| Arm/Group Description | 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. |
| Measure Participants | 0 |
| Title | Number of Participants With Serious and Non-serious Adverse Events |
|---|---|
| Description | Here is the number of serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Time Frame | 37 months and 12 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lenalidomide Maintenance Therapy for Multiple Myeloma |
|---|---|
| Arm/Group Description | 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. |
| Measure Participants | 11 |
| Count of Participants [Participants] |
11
100%
|
| Title | Duration of Response |
|---|---|
| Description | Duration of response is defined as time from response to disease progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be >10mg/dl. |
| Time Frame | participants were followed for the duration of their treatment, an average of 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lenalidomide Maintenance Therapy for Multiple Myeloma |
|---|---|
| Arm/Group Description | 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. |
| Measure Participants | 10 |
| Median (95% Confidence Interval) [Months] |
NA
|
| Title | Progression Free Survival (PFS) |
|---|---|
| Description | PFS is defined as the time from study entry until progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be >10mg/dl. |
| Time Frame | participants were followed for the duration of their treatment, an average of 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lenalidomide Maintenance Therapy for Multiple Myeloma |
|---|---|
| Arm/Group Description | 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. |
| Measure Participants | 11 |
| Median (95% Confidence Interval) [months] |
NA
|
| Title | Natural Killer (NK) Cell Function and Activity |
|---|---|
| Description | Percent of target cell lysis by NK cells |
| Time Frame | participants were followed for the duration of their treatment, an average of 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions. |
| Arm/Group Title | Lenalidomide Maintenance Therapy for Multiple Myeloma |
|---|---|
| Arm/Group Description | 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. |
| Measure Participants | 0 |
| Title | Changes in B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy |
|---|---|
| Description | Percent change in total number of B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy |
| Time Frame | participants were followed for the duration of their treatment, an average of 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions. |
| Arm/Group Title | Lenalidomide Maintenance Therapy for Multiple Myeloma |
|---|---|
| Arm/Group Description | 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. |
| Measure Participants | 0 |
| Title | Expression of Cereblon (CRBN) and How it Relates to Natural Killer (NK) Cell Number and Activity |
|---|---|
| Description | Relative fold change in CRBN and correlation (R2) to NK cell number and activity. |
| Time Frame | participants were followed for the duration of their treatment, an average of 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions. |
| Arm/Group Title | Lenalidomide Maintenance Therapy for Multiple Myeloma |
|---|---|
| Arm/Group Description | 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. |
| Measure Participants | 0 |
Adverse Events
| Time Frame | 37 months and 12 days | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Lenalidomide Maintenance Therapy for Multiple Myeloma | |
| Arm/Group Description | 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. | |
All Cause Mortality |
||
| Lenalidomide Maintenance Therapy for Multiple Myeloma | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | |
Serious Adverse Events |
||
| Lenalidomide Maintenance Therapy for Multiple Myeloma | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Lenalidomide Maintenance Therapy for Multiple Myeloma | ||
| Affected / at Risk (%) | # Events | |
| Total | 11/11 (100%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 5/11 (45.5%) | 11 |
| Eye disorders | ||
| Watering eyes | 1/11 (9.1%) | 1 |
| Gastrointestinal disorders | ||
| Constipation | 2/11 (18.2%) | 2 |
| Diarrhea | 2/11 (18.2%) | 2 |
| Hemorrhoids | 1/11 (9.1%) | 1 |
| Vomiting | 1/11 (9.1%) | 1 |
| General disorders | ||
| Edema face | 1/11 (9.1%) | 2 |
| Fatigue | 2/11 (18.2%) | 3 |
| Fever | 1/11 (9.1%) | 1 |
| Flu like symptoms | 1/11 (9.1%) | 1 |
| Pain | 1/11 (9.1%) | 3 |
| Infections and infestations | ||
| Infections and infestations - Other, dental abscess | 1/11 (9.1%) | 1 |
| Lung infection | 1/11 (9.1%) | 1 |
| Sinusitis | 1/11 (9.1%) | 1 |
| Skin infection | 1/11 (9.1%) | 1 |
| Upper respiratory infection | 2/11 (18.2%) | 2 |
| Injury, poisoning and procedural complications | ||
| Fall | 1/11 (9.1%) | 1 |
| Investigations | ||
| Activated partial thromboplastin time prolonged | 2/11 (18.2%) | 2 |
| Alanine aminotransferase increased | 4/11 (36.4%) | 6 |
| Alkaline phosphatase increased | 4/11 (36.4%) | 6 |
| Aspartate aminotransferase increased | 4/11 (36.4%) | 9 |
| Blood bilirubin increased | 2/11 (18.2%) | 3 |
| CPK increased | 3/11 (27.3%) | 6 |
| Creatinine increased | 5/11 (45.5%) | 11 |
| Lymphocyte count decreased | 8/11 (72.7%) | 18 |
| Neutrophil count decreased | 8/11 (72.7%) | 25 |
| Platelet count decreased | 4/11 (36.4%) | 9 |
| White blood cell decreased | 10/11 (90.9%) | 29 |
| Metabolism and nutrition disorders | ||
| Hypermagnesemia | 1/11 (9.1%) | 1 |
| Hypernatremia | 2/11 (18.2%) | 3 |
| Hyperuricemia | 1/11 (9.1%) | 1 |
| Hypoalbuminemia | 3/11 (27.3%) | 4 |
| Hypocalcemia | 2/11 (18.2%) | 2 |
| Hypokalemia | 2/11 (18.2%) | 2 |
| Hypomagnesemia | 1/11 (9.1%) | 1 |
| Hypophosphatemia | 4/11 (36.4%) | 6 |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 2/11 (18.2%) | 2 |
| Chest wall pain | 1/11 (9.1%) | 1 |
| Myalgia | 5/11 (45.5%) | 5 |
| Pain in extremity | 1/11 (9.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, primary prostate cancer | 1/11 (9.1%) | 1 |
| Nervous system disorders | ||
| Dizziness | 1/11 (9.1%) | 1 |
| Dysgeusia | 1/11 (9.1%) | 1 |
| Paresthesia | 1/11 (9.1%) | 1 |
| Peripheral sensory neuropathy | 2/11 (18.2%) | 2 |
| Somnolence | 1/11 (9.1%) | 1 |
| Psychiatric disorders | ||
| Insomnia | 1/11 (9.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Postnasal drip | 1/11 (9.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Dry skin | 4/11 (36.4%) | 4 |
| Pruritus | 2/11 (18.2%) | 2 |
| Rash maculo-papular | 2/11 (18.2%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Dickran Kazandijian |
|---|---|
| Organization | National Cancer Institute |
| Phone | 301-451-2677 |
| kazandijiandg@nih.gov |
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