Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis
Study Details
Study Description
Brief Summary
The goal of this clinical trial is to determine the toxicity and also the efficacy of a treatment that includes the following treatment: Two medications, bortezomib and dexamethasone (or BD), followed by autologous stem cell transplantation, and a prolonged course of treatment with bortezomib and dexamethasone after transplantation. This type of treatment has been very effective in multiple myeloma. However, there is little experience with this treatment in patients who have Monoclonal Immunoglobulin Deposition Disease (MIDD) or amyloidosis. The investigators and others have treated patients who have MIDD and amyloidosis with bortezomib and autologous stem cell transplantation and have had success with this treatment. But the combination of autologous transplant with BD given before and after the transplant is a new way of treating these diseases, which the investigators believe will be very effective.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bortezomib/Dexamethasone (BD) , STC & Maintenance BD This is a pilot study to gain information and estimate the toxicity/tolerability of 1-3 cycles of BD, followed by HDM/ASCT, and maintenance therapy with BD in patients with MIDD associated with multiple myeloma and AL amyloidosis. |
Drug: Bortezomib/Dexamethasone (BD), Followed By Autologous STC & Maintenance Bortezomib/Dexamethasone
The treatment has three phases:
1) Initial treatment phase: This phase consists of 1-3 21-day-cycles of a combination regimen that includes bortezomib 1.3 mg/m2, IV or Subcutaneous Injection (SQ), on days 1, 4, 8, and 11; and dexamethasone 40 mg PO or IV, on days 1, 4, 8, and 11. Stem cell mobilization and HDM/ASCT. Post-ASCT consolidation/maintenance treatment phase: This phase consists of six cycles of bortezomib 1.3 mg/m2, IV or (SQ) with dexamethasone 20 mg PO or IV administered on days 1, 8, 15, and 22 every 12 weeks +/- 2 weeks. Long Term Follow Up will cease when all patients on study have fulfilled the requirements for at least five follow up appointments.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Experiencing Progression Free Survival at 12 Months [12 months]
of a 3-phase comprehensive treatment approach including induction with BD followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
- Participants Evaluated for Toxicity [2 years]
Toxicities will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
Secondary Outcome Measures
- To Estimate the Hematologic Response Rate [2 years]
[Complete Response (CR) (Normalization of the free light chain (FLC)levels and ratio; Negative serum and urine ; <5% plasma cells in bone marrow), Very Good Partial Response (VGPR) (Reduction in the dFLC (difference between involved [iFLC] and uninvolved FLC) to<4mg/dl) and Partial Response (PR)] (>/= 50% reduction in the dFLC), achieved at 12 month, and at 24 months post-initiation of treatment following the 3-phase comprehensive treatment approach.
- Organ Response - Cardiac Involvement at 12 Months [12 months]
12 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
- Progression Free Survival at 24 Months [24 months]
following the 3-phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
- Organ Response - Cardiac Involvement at 24 Months [24 months]
24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
- Organ Response - Renal Involvement at 12 Months [12 months]
12 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
- Organ Response - Renal Involvement at 24 Months [24 months]
24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age > or = to 18
-
New diagnosis of MIDD or AL amyloidosis based on pathologic findings confirmed at Memorial Sloan Kettering Cancer Center.
-
Patients must show the ability to understand the investigational nature of the treatment and to give voluntary informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
-
Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of bortezomib, or agree to completely abstain from heterosexual intercourse.
-
Male subjects, even if surgically sterilized (i.e., status post-vasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.
-
Adequate organ function defined as follows: Absolute granulocytes > 1,000/mm3 and platelets > 70,000/mm3, unless low granulocyte and platelets counts are due to multiple myeloma; total bilirubin < 1.5 ULN; AST, ALT, and alkaline phosphatase < 3 times upper limit of laboratory normal; LVEF > 50% by MUGA or ECHO (the method used at baseline must be used for later monitoring); DLCO > 50 % confirmed at MSKCC; elevated creatinine is not a contraindication to enrollment
-
Performance status (ECOG) < or = to 2
Exclusion Criteria:
-
Patient has received other investigational drugs with 14 days before enrollment
-
Prior initial treatment chemotherapy for MIDD, AL amyloidosis or multiple myeloma with the exception of one cycle of high dose dexamethasone
-
Prior bortezomib treatment
-
Myocardial infarction within 6 months prior to enrollment or New York Heart Association Class III or IV heart failure (see Appendix 20.2), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
-
Pregnant or lactating women are ineligible. A pregnancy test will be performed on each fertile premenopausal female 2 weeks prior to entry into the study. Treatment may not begin until the results of the pregnancy test are ascertained. All patients (men and women) must agree to use medically approved contraceptive measures for at least 4 weeks before starting therapy, during therapy, and for at least 3 months after therapy has stopped.
-
Pre existing neuropathy, sensory or neuropathic pain findings, grade 2 or higher on the NCI CTC neurotoxicity scale.
-
Concurrent active malignancy other than non melanoma skin cancers or carcinoma in situ of the cervix. Patients with previous malignancies, but which have not required anti tumor treatment within the preceding 24 months will be allowed to enter the trial. Patients with a history of a T1a or b prostate cancer (detected incidentally at TURP and comprising less than 5% of resected tissue) may participate if the PSA has remained within normal limits since TURP.
-
Patients with known HIV positivity or AIDS related illness. This is based upon the possibility of increasing HIV viral load with therapy
-
Any other medical condition or reason that, in the principal investigator's opinion, makes the patient unsuitable to participate in a clinical trial
-
Patients with a history of hypersensitivity reactions attributed to bortezomib, boron, or mannitol.
-
Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
| 2 | Memorial Sloan Kettering Commack | Commack | New York | United States | 11725 |
| 3 | Memorial Sloan Kettering Westchester | Harrison | New York | United States | 10604 |
| 4 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 5 | Memorial Sloan Kettering Rockville Centre | Rockville Centre | New York | United States |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- Millennium Pharmaceuticals, Inc.
Investigators
- Principal Investigator: Hani Hassoun, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 11-061
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Amyloidosis | Monoclonal Ig DepositionDisease (MIDD) |
|---|---|---|
| Arm/Group Description | Participants with newly diagnosed AL amyloidosis | Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD) |
| Period Title: Overall Study | ||
| STARTED | 19 | 1 |
| COMPLETED | 19 | 1 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Amyloidosis | Monoclonal Ig DepositionDisease (MIDD) | Total |
|---|---|---|---|
| Arm/Group Description | Participants with newly diagnosed AL amyloidosis | Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD) | Total of all reporting groups |
| Overall Participants | 19 | 1 | 20 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
60
|
63
|
60
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
6
31.6%
|
0
0%
|
6
30%
|
| Male |
13
68.4%
|
1
100%
|
14
70%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
19
100%
|
1
100%
|
20
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
5.3%
|
0
0%
|
1
5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
5.3%
|
0
0%
|
1
5%
|
| White |
16
84.2%
|
1
100%
|
17
85%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
5.3%
|
0
0%
|
1
5%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
19
100%
|
1
100%
|
20
100%
|
Outcome Measures
| Title | Percentage of Participants Experiencing Progression Free Survival at 12 Months |
|---|---|
| Description | of a 3-phase comprehensive treatment approach including induction with BD followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected for MIDD group. |
| Arm/Group Title | Amyloidosis |
|---|---|
| Arm/Group Description | Participants with newly diagnosed AL amyloidosis |
| Measure Participants | 19 |
| Number (95% Confidence Interval) [percentage of patients] |
84
|
| Title | Participants Evaluated for Toxicity |
|---|---|
| Description | Toxicities will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Amyloidosis | Monoclonal Ig DepositionDisease (MIDD) |
|---|---|---|
| Arm/Group Description | Participants with newly diagnosed AL amyloidosis | Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD) |
| Measure Participants | 19 | 1 |
| Count of Participants [Participants] |
19
100%
|
1
100%
|
| Title | To Estimate the Hematologic Response Rate |
|---|---|
| Description | [Complete Response (CR) (Normalization of the free light chain (FLC)levels and ratio; Negative serum and urine ; <5% plasma cells in bone marrow), Very Good Partial Response (VGPR) (Reduction in the dFLC (difference between involved [iFLC] and uninvolved FLC) to<4mg/dl) and Partial Response (PR)] (>/= 50% reduction in the dFLC), achieved at 12 month, and at 24 months post-initiation of treatment following the 3-phase comprehensive treatment approach. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Amyloidosis | Monoclonal Ig DepositionDisease (MIDD) |
|---|---|---|
| Arm/Group Description | Participants with newly diagnosed AL amyloidosis | Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD) |
| Measure Participants | 19 | 1 |
| Complete Response (CR) |
7
36.8%
|
0
0%
|
| Partial Response (PR) |
4
21.1%
|
0
0%
|
| Progression of Disease (POD) |
1
5.3%
|
0
0%
|
| Stable Disease (SD) |
1
5.3%
|
0
0%
|
| Very Good Partial Response (VGPR) |
6
31.6%
|
1
100%
|
| Title | Organ Response - Cardiac Involvement at 12 Months |
|---|---|
| Description | 12 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Amyloidosis |
|---|---|
| Arm/Group Description | Participants with newly diagnosed AL amyloidosis |
| Measure Participants | 19 |
| Participants without cardiac involvement |
7
36.8%
|
| Cardiac involvement, improved |
8
42.1%
|
| Cardiac involvement, progressed |
2
10.5%
|
| Cardiac involvement, died during induction |
2
10.5%
|
| Title | Progression Free Survival at 24 Months |
|---|---|
| Description | following the 3-phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Amyloidosis |
|---|---|
| Arm/Group Description | Participants with newly diagnosed AL amyloidosis |
| Measure Participants | 19 |
| Number (95% Confidence Interval) [percentage of patients] |
68
|
| Title | Organ Response - Cardiac Involvement at 24 Months |
|---|---|
| Description | 24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Amyloidosis |
|---|---|
| Arm/Group Description | Participants with newly diagnosed AL amyloidosis |
| Measure Participants | 19 |
| Participants without cardiac involvement |
7
36.8%
|
| Cardiac involvement, improved |
8
42.1%
|
| Cardiac involvement, progressed |
2
10.5%
|
| Cardiac involvement, died during induction |
2
10.5%
|
| Title | Organ Response - Renal Involvement at 12 Months |
|---|---|
| Description | 12 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Amyloidosis |
|---|---|
| Arm/Group Description | Participants with newly diagnosed AL amyloidosis |
| Measure Participants | 19 |
| No renal involvment |
7
36.8%
|
| Renal involvment, improved |
9
47.4%
|
| Renal involvment, profressed |
2
10.5%
|
| Renal involvment, died |
1
5.3%
|
| Title | Organ Response - Renal Involvement at 24 Months |
|---|---|
| Description | 24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 1 participants died at the previous 12 month follow up point |
| Arm/Group Title | Amyloidosis |
|---|---|
| Arm/Group Description | Participants with newly diagnosed AL amyloidosis |
| Measure Participants | 18 |
| No renal involvement |
7
36.8%
|
| Renal Involvement, improved |
9
47.4%
|
| Normal Renal Function after Kidney Transplant |
2
10.5%
|
Adverse Events
| Time Frame | 1 year | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Amyloidosis | Monoclonal Ig DepositionDisease (MIDD) | ||
| Arm/Group Description | Participants with newly diagnosed AL amyloidosis | Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD) | ||
All Cause Mortality |
||||
| Amyloidosis | Monoclonal Ig DepositionDisease (MIDD) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/19 (36.8%) | 0/1 (0%) | ||
Serious Adverse Events |
||||
| Amyloidosis | Monoclonal Ig DepositionDisease (MIDD) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/19 (89.5%) | 1/1 (100%) | ||
| Cardiac disorders | ||||
| Cardiac arrest | 2/19 (10.5%) | 0/1 (0%) | ||
| Atrial fibrillation | 1/19 (5.3%) | 0/1 (0%) | ||
| Gastrointestinal disorders | ||||
| Diarrhea | 1/19 (5.3%) | 0/1 (0%) | ||
| Constipation | 1/19 (5.3%) | 0/1 (0%) | ||
| Abdominal pain | 1/19 (5.3%) | 0/1 (0%) | ||
| Upper gastrointestinal hemorrhage | 1/19 (5.3%) | 1/1 (100%) | ||
| Gastrointestinal disorders - Other, specify | 1/19 (5.3%) | 0/1 (0%) | ||
| General disorders | ||||
| Sudden death NOS | 1/19 (5.3%) | 0/1 (0%) | ||
| Infections and infestations | ||||
| Lung infection | 2/19 (10.5%) | 0/1 (0%) | ||
| Upper respiratory infection | 2/19 (10.5%) | 0/1 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Fall | 1/19 (5.3%) | 0/1 (0%) | ||
| Hip fracture | 0/19 (0%) | 1/1 (100%) | ||
| Investigations | ||||
| Creatinine increased | 1/19 (5.3%) | 0/1 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 2/19 (10.5%) | 0/1 (0%) | ||
| Hypokalemia | 1/19 (5.3%) | 0/1 (0%) | ||
| Hyperkalemia | 1/19 (5.3%) | 0/1 (0%) | ||
| Nervous system disorders | ||||
| Syncope | 2/19 (10.5%) | 0/1 (0%) | ||
| Depressed level of consciousness | 1/19 (5.3%) | 0/1 (0%) | ||
| Renal and urinary disorders | ||||
| Acute kidney injury | 3/19 (15.8%) | 0/1 (0%) | ||
| Renal and urinary disorders - Other, specify | 1/19 (5.3%) | 0/1 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Hypoxia | 1/19 (5.3%) | 0/1 (0%) | ||
| Vascular disorders | ||||
| Hypotension | 4/19 (21.1%) | 0/1 (0%) | ||
| Hypertension | 1/19 (5.3%) | 0/1 (0%) | ||
| Thromboembolic event | 1/19 (5.3%) | 0/1 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Amyloidosis | Monoclonal Ig DepositionDisease (MIDD) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/19 (100%) | 1/1 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 1/19 (5.3%) | 0/1 (0%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 1/19 (5.3%) | 0/1 (0%) | ||
| Cardiac disorders - Other, specify | 6/19 (31.6%) | 0/1 (0%) | ||
| Chest pain - cardiac | 1/19 (5.3%) | 0/1 (0%) | ||
| Palpitations | 1/19 (5.3%) | 0/1 (0%) | ||
| Ventricular tachycardia | 3/19 (15.8%) | 0/1 (0%) | ||
| Ear and labyrinth disorders | ||||
| Ear and labyrinth disorders - Other, specify | 1/19 (5.3%) | 0/1 (0%) | ||
| Ear pain | 1/19 (5.3%) | 0/1 (0%) | ||
| Eye disorders | ||||
| Eye disorders - Other, specify | 2/19 (10.5%) | 0/1 (0%) | ||
| Periorbital edema | 1/19 (5.3%) | 0/1 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/19 (5.3%) | 0/1 (0%) | ||
| Bloating | 1/19 (5.3%) | 0/1 (0%) | ||
| Constipation | 7/19 (36.8%) | 0/1 (0%) | ||
| Diarrhea | 8/19 (42.1%) | 1/1 (100%) | ||
| Dyspepsia | 2/19 (10.5%) | 0/1 (0%) | ||
| Esophagitis | 1/19 (5.3%) | 0/1 (0%) | ||
| Flatulence | 1/19 (5.3%) | 0/1 (0%) | ||
| Hemorrhoids | 1/19 (5.3%) | 0/1 (0%) | ||
| Lower gastrointestinal hemorrhage | 1/19 (5.3%) | 0/1 (0%) | ||
| Mucositis oral | 1/19 (5.3%) | 0/1 (0%) | ||
| Nausea | 7/19 (36.8%) | 0/1 (0%) | ||
| Vomiting | 3/19 (15.8%) | 0/1 (0%) | ||
| General disorders | ||||
| Edema limbs | 5/19 (26.3%) | 0/1 (0%) | ||
| Fatigue | 10/19 (52.6%) | 0/1 (0%) | ||
| Fever | 2/19 (10.5%) | 0/1 (0%) | ||
| Localized edema | 1/19 (5.3%) | 1/1 (100%) | ||
| Immune system disorders | ||||
| Allergic reaction | 1/19 (5.3%) | 0/1 (0%) | ||
| Cytokine release syndrome | 3/19 (15.8%) | 0/1 (0%) | ||
| Infections and infestations | ||||
| Infections and infestations - Other, specify | 3/19 (15.8%) | 0/1 (0%) | ||
| Lung infection | 1/19 (5.3%) | 0/1 (0%) | ||
| Skin infection | 1/19 (5.3%) | 0/1 (0%) | ||
| Upper respiratory infection | 3/19 (15.8%) | 0/1 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Bruising | 1/19 (5.3%) | 0/1 (0%) | ||
| Investigations | ||||
| Activated partial thromboplastin time prolonged | 7/19 (36.8%) | 0/1 (0%) | ||
| Alanine aminotransferase increased | 13/19 (68.4%) | 1/1 (100%) | ||
| Alkaline phosphatase increased | 17/19 (89.5%) | 1/1 (100%) | ||
| Aspartate aminotransferase increased | 16/19 (84.2%) | 1/1 (100%) | ||
| Blood bilirubin increased | 7/19 (36.8%) | 0/1 (0%) | ||
| CPK increased | 2/19 (10.5%) | 0/1 (0%) | ||
| Cholesterol high | 9/19 (47.4%) | 0/1 (0%) | ||
| Creatinine increased | 12/19 (63.2%) | 1/1 (100%) | ||
| Hemoglobin increased | 3/19 (15.8%) | 0/1 (0%) | ||
| INR increased | 11/19 (57.9%) | 1/1 (100%) | ||
| Lipase increased | 2/19 (10.5%) | 1/1 (100%) | ||
| Lymphocyte count decreased | 17/19 (89.5%) | 1/1 (100%) | ||
| Neutrophil count decreased | 15/19 (78.9%) | 0/1 (0%) | ||
| Platelet count decreased | 19/19 (100%) | 1/1 (100%) | ||
| Serum amylase increased | 2/19 (10.5%) | 0/1 (0%) | ||
| Weight gain | 2/19 (10.5%) | 0/1 (0%) | ||
| Weight loss | 2/19 (10.5%) | 0/1 (0%) | ||
| White blood cell decreased | 17/19 (89.5%) | 1/1 (100%) | ||
| Metabolism and nutrition disorders | ||||
| Hypercalcemia | 4/19 (21.1%) | 0/1 (0%) | ||
| Hyperglycemia | 19/19 (100%) | 1/1 (100%) | ||
| Hyperkalemia | 13/19 (68.4%) | 1/1 (100%) | ||
| Hypermagnesemia | 6/19 (31.6%) | 0/1 (0%) | ||
| Hypernatremia | 8/19 (42.1%) | 1/1 (100%) | ||
| Hypertriglyceridemia | 7/19 (36.8%) | 0/1 (0%) | ||
| Hypoalbuminemia | 19/19 (100%) | 1/1 (100%) | ||
| Hypocalcemia | 17/19 (89.5%) | 1/1 (100%) | ||
| Hypoglycemia | 15/19 (78.9%) | 0/1 (0%) | ||
| Hypokalemia | 13/19 (68.4%) | 0/1 (0%) | ||
| Hypomagnesemia | 10/19 (52.6%) | 1/1 (100%) | ||
| Hyponatremia | 15/19 (78.9%) | 0/1 (0%) | ||
| Hypophosphatemia | 6/19 (31.6%) | 1/1 (100%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 3/19 (15.8%) | 0/1 (0%) | ||
| Back pain | 1/19 (5.3%) | 1/1 (100%) | ||
| Generalized muscle weakness | 2/19 (10.5%) | 0/1 (0%) | ||
| Musculoskeletal & conn tissue disorder Other, spec | 3/19 (15.8%) | 0/1 (0%) | ||
| Myalgia | 1/19 (5.3%) | 0/1 (0%) | ||
| Pain | 4/19 (21.1%) | 0/1 (0%) | ||
| Pain in extremity | 1/19 (5.3%) | 0/1 (0%) | ||
| Nervous system disorders | ||||
| Dizziness | 1/19 (5.3%) | 0/1 (0%) | ||
| Headache | 4/19 (21.1%) | 0/1 (0%) | ||
| Nervous system disorders - Other, specify | 2/19 (10.5%) | 0/1 (0%) | ||
| Paresthesia | 2/19 (10.5%) | 0/1 (0%) | ||
| Peripheral motor neuropathy | 3/19 (15.8%) | 0/1 (0%) | ||
| Peripheral sensory neuropathy | 12/19 (63.2%) | 1/1 (100%) | ||
| Presyncope | 1/19 (5.3%) | 0/1 (0%) | ||
| Seizure | 1/19 (5.3%) | 0/1 (0%) | ||
| Syncope | 3/19 (15.8%) | 0/1 (0%) | ||
| Tremor | 1/19 (5.3%) | 0/1 (0%) | ||
| Vasovagal reaction | 1/19 (5.3%) | 0/1 (0%) | ||
| Psychiatric disorders | ||||
| Anxiety | 3/19 (15.8%) | 0/1 (0%) | ||
| Depression | 1/19 (5.3%) | 0/1 (0%) | ||
| Renal and urinary disorders | ||||
| Hematuria | 1/19 (5.3%) | 0/1 (0%) | ||
| Renal and urinary disorders - Other, specify | 1/19 (5.3%) | 0/1 (0%) | ||
| Urinary frequency | 2/19 (10.5%) | 0/1 (0%) | ||
| Urinary incontinence | 1/19 (5.3%) | 0/1 (0%) | ||
| Urinary urgency | 1/19 (5.3%) | 0/1 (0%) | ||
| Reproductive system and breast disorders | ||||
| Vaginal pain | 1/19 (5.3%) | 0/1 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Allergic rhinitis | 1/19 (5.3%) | 0/1 (0%) | ||
| Cough | 2/19 (10.5%) | 1/1 (100%) | ||
| Dyspnea | 7/19 (36.8%) | 0/1 (0%) | ||
| Hypoxia | 1/19 (5.3%) | 0/1 (0%) | ||
| Nasal congestion | 2/19 (10.5%) | 0/1 (0%) | ||
| Pulmonary hypertension | 1/19 (5.3%) | 0/1 (0%) | ||
| Wheezing | 1/19 (5.3%) | 0/1 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Pruritus | 3/19 (15.8%) | 0/1 (0%) | ||
| Rash maculo-papular | 2/19 (10.5%) | 0/1 (0%) | ||
| Vascular disorders | ||||
| Hypertension | 3/19 (15.8%) | 1/1 (100%) | ||
| Hypotension | 5/19 (26.3%) | 0/1 (0%) | ||
| Thromboembolic event | 1/19 (5.3%) | 0/1 (0%) | ||
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 | Dr. Hani Hassoun |
|---|---|
| Organization | Memorial Sloan Kettering Cancer Center |
| Phone | 212-639-3228 |
| hassounh@mskcc.org |
- 11-061