Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma
Study Details
Study Description
Brief Summary
The purpose of this research is to estimate the effectiveness of a response adapted approach with the use of the drug, lenalidomide in the treatment of older adults with newly diagnosed standard risk multiple myeloma. This means that participants will be given the study drug, lenalidomide but depending on how they respond to this drug they may also be given dexamethasone and/or prednisone to help with their treatment.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
Summary: Patients will be started on the study drug, lenalidomide on Day 1, Cycle 1. Lenalidomide is a capsule that is to be taken orally (by mouth). If the patient's disease progresses after 2 cycles of therapy, a low dose of dexamethasone will be added. If the patient's disease is stable after 2 cycles of therapy, the use of an alternate corticosteroid (prednisone) will be added to the lenalidomide therapy they are receiving. Dexamethasone and prednisone are in tablet form and will be taken orally (by mouth). However, if the patient has a minimal response after an additional 2 cycles of lenalidomide therapy, the therapy will be continued until their disease progresses. See the intervention descriptions for further details.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Response Adapted Therapy Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. |
Drug: Lenalidomide
Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;
Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;
Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;
Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;
Dose Level -4: Discontinue
Other Names:
Drug: Prednisone
Starting Dose: 100 mg PO days 1-5 every 28 days;
Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;
Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;
Dose level -3: Discontinue
Drug: Dexamethasone
Starting Dose: 40 mg daily on days 1 - 4 every 28 days;
Dose level -1: 20 mg daily on days 1 - 4 every 28 days;
Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;
Dose level -2: 10 mg daily on days 1 - 4 every 28 days;
Dose level -3: Discontinue
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Combined Therapy - Median Progression Free Survival [up to 36 months]
Progression free survival (PFS) of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (i.e. time from start of lenalidomide to failure of lenalidomide and low dose dexamethasone)
Secondary Outcome Measures
- Response Rate [Every 8 weeks up to 12 months]
Response rate in older adults with mildly symptomatic multiple myeloma to single agent lenalidomide, lenalidomide prednisone and lenalidomide low dose dexamethasone in patients with suboptimal responses to lenalidomide monotherapy. The study used the uniform response assessment of the International Myeloma Working Group with the addition of MR (minimal response) (Durie et al, 2006; Kumar et al, 2016). MR was defined as a 25-49% decrease in serum M spike, and a 50-89% improvement in urine M spike. For patients without a measurable serum or urine M spike, a 25-49% decrease in the difference between the involved and uninvolved free light chains was required. The response in this trial is defined as complete remission (CR), stringent complete remission (SRC), very good partial remission (VGPR) and partial remission (PR) and minimal response (MR).
- Number of Participants With Serious Adverse Events [Day 1 through Off Study Date, an average of 48 months]
Number of participants with serious adverse events
- Single Agent - Median Progressive Free Survival (PFS) [First measure at 8 weeks]
The progression free survival of patients treated with single agent lenalidomide
- Number of Participants With 1 Year Overall Survival (OS) [1 Year]
The 1 year overall survival of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Understand and voluntarily sign an informed consent form
-
Age ≥65 years or not eligible for high dose therapy and autologous stem cell transplant
-
Able to adhere to study visit schedule and other protocol requirements
-
Diagnosed with multiple myeloma and considered to have active disease. Patients must not have received an active chemotherapy regimen or Dexamethasone. Patients may have received palliative radiotherapy at least 2 weeks prior to the study start.
-
Measurable myeloma paraprotein levels in serum (≥ 0.5 g/dL), urine (≥ 0.2 g excreted in a 24-hour urine collection sample) or by serum free light chains (involved free light chain greater than 100mg/L)
-
Eastern Cooperative Group (ECOG) Performance Status of 0 or 1
-
Serum bilirubin levels ≤1.5 times the upper limit of the normal (ULN) range for the laboratory
-
Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) levels ≤2 x ULN
-
Adequate bone marrow function: Absolute neutrophil count ≥ 1,000 cells/mm³ (1.0 x 10^9/L); Platelets ≥ 100,000 /mm³
-
Hemoglobin > 8 g/dL
-
Adequate renal function: Calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula
-
Low risk myeloma is defined as the absence of the following adverse features[21]: t(4;14) by FISH or metaphase cytogenetics; t(14,16) or t(14;20) by FISH or metaphase cytogenetics; Deletion 17q13 by FISH; Deletion 13 by metaphase analysis; Aneuploidy by metaphase analysis; Β2 microglobulin > 5.5.
-
Able to tolerate one of the following thromboprophylactic strategies: aspirin, low molecular weight heparin or warfarin (coumadin)
-
Must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
-
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-international units per milliliter (mIU/mL) within 10 14 days prior to and again within 24 hours of prescribing lenalidomide (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 4 weeks before taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy.
Exclusion Criteria:
-
Ongoing severe infection requiring intravenous antibiotic treatment
-
Life expectancy of less than 3 months
-
Performance status of 2, 3 or 4
-
Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the patient has been disease-free for at least 2 years
-
Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
-
Uncontrolled medical problems such as diabetes mellitus, congestive heart failure, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma.
-
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
-
Pregnant or lactating
-
Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
-
Known hypersensitivity to thalidomide
-
Use of any other experimental drug or therapy within 28 days of baseline.
-
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
-
Any prior use of lenalidomide
-
Concurrent use of other anti-cancer agents or treatments
-
Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
Sponsors and Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- Celgene
Investigators
- Principal Investigator: Rachid Baz, M.D., H. Lee Moffitt Cancer Center and Research Institute
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- MCC-16018
- 108562
- RV-MM-PI-0454
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Response Adapted Therapy |
---|---|
Arm/Group Description | Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; Dose level -1: 20 mg daily on days 1 - 4 every 28 days; Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; Dose level -2: 10 mg daily on days 1 - 4 every 28 days; Dose level -3: Discontinue |
Period Title: Overall Study | |
STARTED | 27 |
COMPLETED | 25 |
NOT COMPLETED | 2 |
Baseline Characteristics
Arm/Group Title | Response Adapted Therapy |
---|---|
Arm/Group Description | Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; Dose level -1: 20 mg daily on days 1 - 4 every 28 days; Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; Dose level -2: 10 mg daily on days 1 - 4 every 28 days; Dose level -3: Discontinue |
Overall Participants | 27 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
0
0%
|
>=65 years |
27
100%
|
Sex: Female, Male (Count of Participants) | |
Female |
11
40.7%
|
Male |
16
59.3%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
2
7.4%
|
Not Hispanic or Latino |
25
92.6%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
2
7.4%
|
White |
25
92.6%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (participants) [Number] | |
United States |
27
100%
|
Outcome Measures
Title | Combined Therapy - Median Progression Free Survival |
---|---|
Description | Progression free survival (PFS) of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (i.e. time from start of lenalidomide to failure of lenalidomide and low dose dexamethasone) |
Time Frame | up to 36 months |
Outcome Measure Data
Analysis Population Description |
---|
Number of participants who received response adaptive therapy |
Arm/Group Title | Response Adapted Therapy |
---|---|
Arm/Group Description | Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; Dose level -1: 20 mg daily on days 1 - 4 every 28 days; Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; Dose level -2: 10 mg daily on days 1 - 4 every 28 days; Dose level -3: Discontinue |
Measure Participants | 9 |
Median (95% Confidence Interval) [months] |
36
|
Title | Response Rate |
---|---|
Description | Response rate in older adults with mildly symptomatic multiple myeloma to single agent lenalidomide, lenalidomide prednisone and lenalidomide low dose dexamethasone in patients with suboptimal responses to lenalidomide monotherapy. The study used the uniform response assessment of the International Myeloma Working Group with the addition of MR (minimal response) (Durie et al, 2006; Kumar et al, 2016). MR was defined as a 25-49% decrease in serum M spike, and a 50-89% improvement in urine M spike. For patients without a measurable serum or urine M spike, a 25-49% decrease in the difference between the involved and uninvolved free light chains was required. The response in this trial is defined as complete remission (CR), stringent complete remission (SRC), very good partial remission (VGPR) and partial remission (PR) and minimal response (MR). |
Time Frame | Every 8 weeks up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
1 participant could not be evaluated for response. |
Arm/Group Title | Response Adapted Therapy | Single Agent Lenalidomide |
---|---|---|
Arm/Group Description | Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. | Participants treated with single agent lenalidomide |
Measure Participants | 9 | 26 |
Complete Response & Stringent Complete Response |
1
3.7%
|
4
NaN
|
Very Good Partial Response (VGPR) |
1
3.7%
|
3
NaN
|
Partial Response (PR) |
2
7.4%
|
12
NaN
|
Minimal Response (MR) |
5
18.5%
|
4
NaN
|
Stable Disease |
0
0%
|
3
NaN
|
Overall Response >/= PR |
4
14.8%
|
19
NaN
|
Title | Number of Participants With Serious Adverse Events |
---|---|
Description | Number of participants with serious adverse events |
Time Frame | Day 1 through Off Study Date, an average of 48 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Response Adapted Therapy |
---|---|
Arm/Group Description | Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; Dose level -1: 20 mg daily on days 1 - 4 every 28 days; Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; Dose level -2: 10 mg daily on days 1 - 4 every 28 days; Dose level -3: Discontinue |
Measure Participants | 27 |
Number [participants] |
20
74.1%
|
Title | Single Agent - Median Progressive Free Survival (PFS) |
---|---|
Description | The progression free survival of patients treated with single agent lenalidomide |
Time Frame | First measure at 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Single Agent |
---|---|
Arm/Group Description | Participants who were treated with single agent lenalidomide only |
Measure Participants | 18 |
Median (95% Confidence Interval) [months] |
29
|
Title | Number of Participants With 1 Year Overall Survival (OS) |
---|---|
Description | The 1 year overall survival of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach |
Time Frame | 1 Year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Response Adapted Therapy |
---|---|
Arm/Group Description | Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; Dose level -1: 20 mg daily on days 1 - 4 every 28 days; Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; Dose level -2: 10 mg daily on days 1 - 4 every 28 days; Dose level -3: Discontinue |
Measure Participants | 27 |
Number [participants] |
27
100%
|
Adverse Events
Time Frame | Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | All Participants | |
Arm/Group Description | All participants treated with Lenalidomide, prednisone and lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. | |
All Cause Mortality |
||
All Participants | ||
Affected / at Risk (%) | # Events | |
Total | 2/27 (7.4%) | |
Serious Adverse Events |
||
All Participants | ||
Affected / at Risk (%) | # Events | |
Total | 20/27 (74.1%) | |
Cardiac disorders | ||
General Cardiac Disorders - Other | 3/27 (11.1%) | 4 |
Hypertension | 1/27 (3.7%) | 2 |
Hypotension | 2/27 (7.4%) | 2 |
Gastrointestinal disorders | ||
Dehydration | 1/27 (3.7%) | 1 |
Diarrhea | 1/27 (3.7%) | 1 |
Gastrointestinal disorders, other | 1/27 (3.7%) | 1 |
Colon Obstruction | 1/27 (3.7%) | 1 |
Hemorrhage, Stomach | 1/27 (3.7%) | 1 |
Cholecystitis | 1/27 (3.7%) | 1 |
General disorders | ||
Coagulation | 1/27 (3.7%) | 1 |
General disorders - Other | 1/27 (3.7%) | 1 |
Fever | 1/27 (3.7%) | 2 |
Death | 1/27 (3.7%) | 1 |
Chest wall pain | 1/27 (3.7%) | 1 |
Limb pain | 2/27 (7.4%) | 2 |
Pain -Other | 1/27 (3.7%) | 1 |
Infections and infestations | ||
Colitis, Infectious (e.g. Clostridium difficile) | 2/27 (7.4%) | 2 |
Febrile neutropenia | 3/27 (11.1%) | 3 |
Infection -Blood | 2/27 (7.4%) | 2 |
Infection - Lung | 3/27 (11.1%) | 3 |
Infection - Other | 1/27 (3.7%) | 2 |
Cellulitis | 3/27 (11.1%) | 3 |
Infection - Bladder | 1/27 (3.7%) | 1 |
Injury, poisoning and procedural complications | ||
Fracture | 1/27 (3.7%) | 2 |
Investigations | ||
Hypercalcemia | 1/27 (3.7%) | 1 |
Hyperglycemia | 1/27 (3.7%) | 1 |
Investigations -Other | 1/27 (3.7%) | 1 |
Hypokalemia | 1/27 (3.7%) | 1 |
Musculoskeletal and connective tissue disorders | ||
Muscle weakness | 1/27 (3.7%) | 2 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
Secondary malignancy | 1/27 (3.7%) | 1 |
Nervous system disorders | ||
Confusion | 1/27 (3.7%) | 1 |
Syncope | 1/27 (3.7%) | 1 |
Psychiatric disorders | ||
Mental status | 1/27 (3.7%) | 1 |
Renal and urinary disorders | ||
Renal failure | 1/27 (3.7%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Dyspnea | 2/27 (7.4%) | 2 |
Skin and subcutaneous tissue disorders | ||
Wound complication | 1/27 (3.7%) | 1 |
Vascular disorders | ||
Hemorrhage, CNS | 1/27 (3.7%) | 1 |
Cerebrovascular ischemia | 1/27 (3.7%) | 1 |
Vascular -Other | 1/27 (3.7%) | 3 |
Non-myocardial vascular arterial ischemia | 1/27 (3.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||
All Participants | ||
Affected / at Risk (%) | # Events | |
Total | 27/27 (100%) | |
Blood and lymphatic system disorders | ||
Neutrophils/granulocytes | 25/27 (92.6%) | 265 |
Leukopenia | 22/27 (81.5%) | 264 |
Low platelet count | 20/27 (74.1%) | 78 |
Hemoglobin, low | 16/27 (59.3%) | 75 |
Hemolysis | 1/27 (3.7%) | 1 |
Ear and labyrinth disorders | ||
Pain - external ear | 1/27 (3.7%) | 1 |
Eye disorders | ||
Pain - eye | 1/27 (3.7%) | 2 |
Gastrointestinal disorders | ||
Constipation | 24/27 (88.9%) | 46 |
Diarrhea | 23/27 (85.2%) | 66 |
Nausea | 17/27 (63%) | 37 |
Gastrointestinal disorders - Other | 12/27 (44.4%) | 13 |
Vomiting | 11/27 (40.7%) | 14 |
Dehydration | 9/27 (33.3%) | 12 |
Heartburn/dyspepsia | 7/27 (25.9%) | 9 |
Distension/bloating, Abdominal | 5/27 (18.5%) | 6 |
Dysphagia | 5/27 (18.5%) | 5 |
Flatulence | 2/27 (7.4%) | 3 |
Dry mouth | 2/27 (7.4%) | 3 |
Mucositis/stomatitis - oral cavity | 2/27 (7.4%) | 2 |
Dysgeusia | 2/27 (7.4%) | 2 |
Enteritis | 1/27 (3.7%) | 1 |
Gastritis | 1/27 (3.7%) | 1 |
Hemorrhoids | 1/27 (3.7%) | 2 |
Obstruction, GI - Colon | 1/27 (3.7%) | 1 |
Abdominal Pain NOS | 12/27 (44.4%) | 18 |
Gallbladder pain | 1/27 (3.7%) | 1 |
General disorders | ||
Fatigue | 23/27 (85.2%) | 63 |
Insomnia | 13/27 (48.1%) | 20 |
Fever (in absence of neutropenia) | 10/27 (37%) | 25 |
Rigors/chills | 5/27 (18.5%) | 7 |
Diaphoresis | 4/27 (14.8%) | 4 |
Constitutional symptoms - Other | 3/27 (11.1%) | 3 |
Back pain | 21/27 (77.8%) | 45 |
Pain - extremity/limb | 16/27 (59.3%) | 29 |
Headache | 16/27 (59.3%) | 26 |
Joint pain | 10/27 (37%) | 12 |
Chest wall pain | 6/27 (22.2%) | 7 |
Chest/thorax pain | 5/27 (18.5%) | 7 |
Neck pain | 5/27 (18.5%) | 7 |
Pain-throat/pharynx/larynx | 5/27 (18.5%) | 6 |
Pain - stomach | 4/27 (14.8%) | 4 |
Pain - NOS | 3/27 (11.1%) | 3 |
Bone pain | 2/27 (7.4%) | 3 |
Pain - lymph node | 2/27 (7.4%) | 2 |
Pain - oral, gum | 2/27 (7.4%) | 4 |
Breast pain | 1/27 (3.7%) | 1 |
Buttock pain | 1/27 (3.7%) | 1 |
Pain - dental | 1/27 (3.7%) | 1 |
Pain - face | 1/27 (3.7%) | 1 |
Oral cavity pain | 1/27 (3.7%) | 1 |
Pelvic pain | 1/27 (3.7%) | 1 |
Sinus pain | 1/27 (3.7%) | 1 |
Pain - testicle | 1/27 (3.7%) | 1 |
Edema - limb | 21/27 (77.8%) | 52 |
Edema -head and neck | 3/27 (11.1%) | 4 |
Edema - trunk | 1/27 (3.7%) | 1 |
Gait changes | 5/27 (18.5%) | 8 |
Gingivitus | 2/27 (7.4%) | 2 |
Infections and infestations | ||
Febrile neutropenia | 6/27 (22.2%) | 7 |
Cellulitis | 9/27 (33.3%) | 11 |
Infection -Other | 4/27 (14.8%) | 4 |
Urinary Tract Infection | 4/27 (14.8%) | 4 |
Bronchus infection | 3/27 (11.1%) | 3 |
Eye infection | 2/27 (7.4%) | 2 |
Pneumonia | 3/27 (11.1%) | 3 |
Sinus infection | 3/27 (11.1%) | 3 |
Upper airway infection | 1/27 (3.7%) | 1 |
Conjunctiva infection | 2/27 (7.4%) | 2 |
Peripheral nerve infection | 1/27 (3.7%) | 1 |
Nail infection | 1/27 (3.7%) | 1 |
wound infection | 1/27 (3.7%) | 1 |
Bladder infection | 1/27 (3.7%) | 1 |
Colon infection | 1/27 (3.7%) | 1 |
Tooth infection | 1/27 (3.7%) | 1 |
Mucosal infection | 1/27 (3.7%) | 1 |
Investigations | ||
Hyperglycemia | 9/27 (33.3%) | 13 |
Creatinine | 7/27 (25.9%) | 14 |
Hyperkalemia | 7/27 (25.9%) | 8 |
ALT, SGPT high | 4/27 (14.8%) | 6 |
Hyperbilirubinemia | 4/27 (14.8%) | 9 |
Hypoalbuminemia | 3/27 (11.1%) | 4 |
Alkaline phosphatase | 3/27 (11.1%) | 3 |
Hypokalemia | 3/27 (11.1%) | 5 |
Investigations - Other | 11/27 (40.7%) | 12 |
Hypercalcemia | 2/27 (7.4%) | 3 |
Hypocalcemia | 2/27 (7.4%) | 5 |
Hypoglycemia | 2/27 (7.4%) | 2 |
AST, SGOT | 1/27 (3.7%) | 1 |
Hypomagnesemia | 1/27 (3.7%) | 1 |
Hypernatremia | 1/27 (3.7%) | 1 |
Metabolism and nutrition disorders | ||
Anorexia | 12/27 (44.4%) | 27 |
Weight loss | 8/27 (29.6%) | 11 |
Weight gain | 4/27 (14.8%) | 4 |
Musculoskeletal and connective tissue disorders | ||
Pain - muscle | 3/27 (11.1%) | 3 |
Musculoskeletal and connective tissue disorders - Other | 12/27 (44.4%) | 19 |
Muscle weakess, generalized | 11/27 (40.7%) | 12 |
Muscle weakness, extraocular | 3/27 (11.1%) | 3 |
Muscle weakness, lower extremities | 3/27 (11.1%) | 3 |
Fracture | 3/27 (11.1%) | 3 |
Muscle weakness, trunk | 2/27 (7.4%) | 2 |
Arthritis | 2/27 (7.4%) | 2 |
Myositis | 1/27 (3.7%) | 1 |
Nervous system disorders | ||
Neuropathy, sensory | 19/27 (70.4%) | 38 |
Dizziness | 15/27 (55.6%) | 29 |
Nervous system disorders -Other | 9/27 (33.3%) | 15 |
Tremor | 8/27 (29.6%) | 16 |
Neuropathy, motor | 5/27 (18.5%) | 6 |
Confusion | 2/27 (7.4%) | 3 |
CNS cerebrovascular ischemia | 1/27 (3.7%) | 1 |
Memory impairment | 1/27 (3.7%) | 1 |
Neuropathy, cranial | 1/27 (3.7%) | 1 |
Speech impairment | 1/27 (3.7%) | 1 |
Syncope | 1/27 (3.7%) | 1 |
Psychiatric disorders | ||
Depression | 6/27 (22.2%) | 9 |
Agitation/Iritability | 6/27 (22.2%) | 8 |
Anxiety | 3/27 (11.1%) | 6 |
Personality/Behavior changes | 1/27 (3.7%) | 1 |
Reproductive system and breast disorders | ||
Cough | 16/27 (59.3%) | 28 |
Respiratory, thoracic and mediastinal disorders | ||
Dyspnea | 14/27 (51.9%) | 25 |
Respirator, thoracic and mediastrinal disorders -Other | 9/27 (33.3%) | 14 |
Loss or alteration of voice | 4/27 (14.8%) | 5 |
Bronchospasm, wheezing | 1/27 (3.7%) | 1 |
Paranasal/sinus reaction | 1/27 (3.7%) | 1 |
Obstruction of airway | 1/27 (3.7%) | 1 |
Skin and subcutaneous tissue disorders | ||
Skin and subcutaneous tissue disorders -Other | 14/27 (51.9%) | 27 |
Rash/desquamation | 14/27 (51.9%) | 15 |
Dry skin | 11/27 (40.7%) | 18 |
Pruritus/itching | 10/27 (37%) | 18 |
Rash, erythema multiforme | 10/27 (37%) | 16 |
Brusing | 9/27 (33.3%) | 13 |
Hyperpigmentation | 2/27 (7.4%) | 2 |
Nail changes | 2/27 (7.4%) | 3 |
Rash, acne/acneiform | 2/27 (7.4%) | 2 |
Wound complication, non-infectious | 2/27 (7.4%) | 3 |
Rash | 1/27 (3.7%) | 1 |
Skin breakdown/decubitus ulcer | 1/27 (3.7%) | 1 |
Urticaria | 1/27 (3.7%) | 1 |
Vascular disorders | ||
Flushing | 5/27 (18.5%) | 8 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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 | Rachid Baz, MD |
---|---|
Organization | Moffitt Cancer Center |
Phone | 813-745-3163 |
Rachid.Baz@moffitt.org |
- MCC-16018
- 108562
- RV-MM-PI-0454