Trial Outcomes & Findings for Rituximab, Fludarabine, Mitoxantrone, Dexamethasone (R-FND) Plus Zevalin for High-Risk Follicular Lymphoma (NCT NCT00290511)
NCT ID: NCT00290511
Last Updated: 2022-04-22
Results Overview
Regimen regarded as a success if median TTP can be prolonged to 36 months or greater. Time to Progression measured by the method of Kaplan and Meier, and accompanied by 95% confidence interval. Complete Response (CR) defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays and Partial Response (PR) is defined as a 50% or more reduction in the sum of the products of the diameters of the 6 largest measurable lesions. No new sites of disease. av
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
baseline, 2 and 4 courses, approximately month 8, 9, and 12 months, then restaging every 4 months, then at 2 years every 4-6 months, then yearly until progressive disease or lost to follow up, average of 10 years
Results posted on
2022-04-22
Participant Flow
Recruitment period from June 2004 to May 2009.
Forty-nine patients with Follicular Lymphoma were enrolled in this single site, phase II trial. Two patients were removed after registration and did not start treatment: the first, due to physician's decision; the second, to pursue treatment at home.
Participant milestones
| Measure |
R-FIND + Zevalin
Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
No Treatment Per Protocol
|
2
|
|
Overall Study
Toxicity Assessment
|
47
|
|
Overall Study
Response Assessment
|
45
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
R-FIND + Zevalin
Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Rituximab, Fludarabine, Mitoxantrone, Dexamethasone (R-FND) Plus Zevalin for High-Risk Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
R-FIND + Zevalin
n=49 Participants
Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
|
Bulky Disease
Bulky Disease >/=5 cm
|
24 Participants
n=5 Participants
|
|
Bulky Disease
No bulky disease
|
25 Participants
n=5 Participants
|
|
Ann Arbor Stages
Ann Arbor Stage III
|
7 Participants
n=5 Participants
|
|
Ann Arbor Stages
Ann Arbor Stage IV
|
42 Participants
n=5 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI)
FLIPI Score 3
|
40 Participants
n=5 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI)
FLIPI Score 4
|
6 Participants
n=5 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI)
FLIPI Score 5
|
2 Participants
n=5 Participants
|
|
Bone Marrow Biopsy
Bone Marrow Biopsy - Neg
|
11 Participants
n=5 Participants
|
|
Bone Marrow Biopsy
Bone Marrow Biopsy - Pos
|
37 Participants
n=5 Participants
|
|
Lactate Dehydrogenase (LDH)
LDH, units/ </= 618
|
35 Participants
n=5 Participants
|
|
Lactate Dehydrogenase (LDH)
LDH, units/ >618
|
14 Participants
n=5 Participants
|
|
Beta 2 Microglobulin (B2M)
B2M, mg/l <2.2
|
15 Participants
n=5 Participants
|
|
Beta 2 Microglobulin (B2M)
B2M, mg/l>/= 2.2
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 2 and 4 courses, approximately month 8, 9, and 12 months, then restaging every 4 months, then at 2 years every 4-6 months, then yearly until progressive disease or lost to follow up, average of 10 yearsRegimen regarded as a success if median TTP can be prolonged to 36 months or greater. Time to Progression measured by the method of Kaplan and Meier, and accompanied by 95% confidence interval. Complete Response (CR) defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays and Partial Response (PR) is defined as a 50% or more reduction in the sum of the products of the diameters of the 6 largest measurable lesions. No new sites of disease. av
Outcome measures
| Measure |
R-FIND + Zevalin
n=49 Participants
Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
|
|---|---|
|
Number of Participants With Time to Progression (TTP)
Complete Response (CR)
|
42 Participants
|
|
Number of Participants With Time to Progression (TTP)
Partial Response (PR)
|
4 Participants
|
SECONDARY outcome
Timeframe: cycle 1 and every 2 weeks thereafter until completion of therapy, an average of 10 yearsPopulation: Participants that received YIT treatment.
To assess the tolerance and efficacy of maintenance therapy with YIT. CR: defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays. CRu: defined as "CR unconfirmed" on the basis of minimal residual abnormalities on x-ray such as a residual mass \<25% of original measurement, and or residual indeterminate bone marrow aggregates. PR: a 50% or more reduction in the sum of the products of the diameters of the 6 largest measurable lesions. No new sites of disease. Progressive disease (PD) is also defined by the appearance of new lymph nodes, of other new or worsening sites of disease, such as \> 50% increase in the size of liver and/or spleen, or a \> 50% increase in absolute number of circulating lymphocytes.
Outcome measures
| Measure |
R-FIND + Zevalin
n=38 Participants
Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
|
|---|---|
|
Tolerance and Efficacy of Maintenance Therapy With Yttrium-90 Ibritumomab Tiuxetan (YIT)
Complete Response (CR)
|
37 Participants
|
|
Tolerance and Efficacy of Maintenance Therapy With Yttrium-90 Ibritumomab Tiuxetan (YIT)
Progressive Disease
|
1 Participants
|
SECONDARY outcome
Timeframe: cycle 1 and every 2 weeks thereafter until completion of therapy, an average of 10 yearsTo assess the tolerance and efficacy of maintenance therapy with rituximab. Participants proceeded to the rituximab maintenance program of 6 treatments comprising 1 every 2 months. CR: defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays. CRu: defined as "CR unconfirmed" on the basis of minimal residual abnormalities on x-ray such as a residual mass \<25% of original measurement, and or residual indeterminate bone marrow aggregates. PR: a 50% or more reduction in the sum of the products of the diameters of the 6 largest measurable lesions. No new sites of disease. Progressive disease (PD) is also defined by the appearance of new lymph nodes, of other new or worsening sites of disease, such as \> 50% increase in the size of liver and/or spleen, or a \> 50% increase in absolute number of circulating lymphocytes.
Outcome measures
| Measure |
R-FIND + Zevalin
n=41 Participants
Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
|
|---|---|
|
Tolerance and Efficacy of Maintenance Therapy With Rituximab
Complete Response (CR)
|
38 Participants
|
|
Tolerance and Efficacy of Maintenance Therapy With Rituximab
Progression Disease (PD)
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 5 yearsProgression-free survival time is defined as time from registration/randomization to the date of progression or death from any cause. Median Progression Free Survival estimated by the method of Kaplan and Meier, and accompanied by 95% confidence interval.
Outcome measures
| Measure |
R-FIND + Zevalin
n=47 Participants
Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
|
|---|---|
|
Median Progression Free Survival
|
84 months
Interval 67.0 to
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 10 yearsProgression-free survival time is defined as time from registration/randomization to the date of progression or death from any cause. PFS was estimated by the method of Kaplan and Meier, and accompanied by 95% confidence interval.
Outcome measures
| Measure |
R-FIND + Zevalin
n=47 Participants
Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
|
|---|---|
|
Progression Free Survival at 10 Years
|
49 months
Interval 37.0 to 66.0
|
SECONDARY outcome
Timeframe: up to 5 yearsOS is defined as the interval from first dose of study treatment to the date of death, irrespective of the cause of death; subjects still alive will be censored at the date of the last contact. Median Overall Survival was estimated by the method of Kaplan and Meier, and accompanied by 95% confidence interval.
Outcome measures
| Measure |
R-FIND + Zevalin
n=47 Participants
Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
|
|---|---|
|
Overall Survival
|
143 months
Interval 143.0 to
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 10 yearsOS is defined as the interval from first dose of study treatment to the date of death, irrespective of the cause of death; subjects still alive will be censored at the date of the last contact. Overall Survival Rate estimated by the method of Kaplan and Meier.
Outcome measures
| Measure |
R-FIND + Zevalin
n=47 Participants
Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
|
|---|---|
|
Percentage of Participants With Overall Survival Rate at 10 Years
|
69 percentage of participants
|
Adverse Events
R-FIND + Zevalin
Serious events: 34 serious events
Other events: 46 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
R-FIND + Zevalin
n=49 participants at risk
Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
21/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
32.7%
16/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
Neutropenic Fever
|
4.1%
2/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
Secondary Malignancy
|
4.1%
2/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
Fatigue
|
16.3%
8/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
Pain
|
12.2%
6/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Cardiac disorders
Dyspnea
|
10.2%
5/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Eye disorders
Blurred Vision
|
6.1%
3/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Nervous system disorders
Dizziness
|
6.1%
3/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Infections and infestations
Infection, normal ANC
|
6.1%
3/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Immune system disorders
Allergic reaction
|
4.1%
2/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
Chest pain, non-cardiac
|
4.1%
2/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
Constipation
|
4.1%
2/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
Edema, face
|
4.1%
2/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Immune system disorders
Flushing
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
Rigors/chills
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Cardiac disorders
Syncope
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
Other adverse events
| Measure |
R-FIND + Zevalin
n=49 participants at risk
Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
myalgia
|
8.2%
4/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
nausea
|
46.9%
23/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
neoplasms
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Nervous system disorders
nervous systems disorders - other
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Blood and lymphatic system disorders
neutrophil count decreased
|
10.2%
5/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
non-cardiac chest pain
|
6.1%
3/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
obstruction gastric
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
pain
|
16.3%
8/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
pain in extremity
|
6.1%
3/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Musculoskeletal and connective tissue disorders
peripheral motor neuropathy
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Nervous system disorders
peripheral sensory neuropathy
|
16.3%
8/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Blood and lymphatic system disorders
platelet count decreased
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Skin and subcutaneous tissue disorders
pruritus
|
6.1%
3/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
14.3%
7/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
rectal pain
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Respiratory, thoracic and mediastinal disorders
sinus disorder
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Skin and subcutaneous tissue disorders
skin disorders - other
|
4.1%
2/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Skin and subcutaneous tissue disorders
skin hyperpigmentation
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Skin and subcutaneous tissue disorders
skin infection
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Nervous system disorders
somnolence
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
4.1%
2/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Nervous system disorders
tremor
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Renal and urinary disorders
urinary frequency
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Infections and infestations
urinary tract infection
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Renal and urinary disorders
urinary tract pain
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
vomiting
|
12.2%
6/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Eye disorders
watering eyes
|
22.4%
11/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
Abdonimal distension
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Metabolism and nutrition disorders
ALT increased
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Immune system disorders
Allergic reaction
|
10.2%
5/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Immune system disorders
Allergic rhinitis
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Metabolism and nutrition disorders
AST increased
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
3/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Investigations
Bilirubin increased
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Eye disorders
Blurred Vision
|
28.6%
14/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Infections and infestations
Bronchial infection
|
4.1%
2/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Skin and subcutaneous tissue disorders
Bruising
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
chills
|
20.4%
10/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
constipation
|
44.9%
22/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
12.2%
6/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Investigations
creatinine increased
|
4.1%
2/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
diarrhea
|
36.7%
18/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Nervous system disorders
dizziness
|
36.7%
18/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Skin and subcutaneous tissue disorders
dry skin
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Cardiac disorders
dyspnea
|
18.4%
9/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Eye disorders
ear and labyrinth disorders - other
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
Edema, face
|
8.2%
4/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
edema, limbs
|
16.3%
8/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Blood and lymphatic system disorders
epistaxis
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Eye disorders
eye disorders- other
|
22.4%
11/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
fatigue
|
36.7%
18/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
fever
|
22.4%
11/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
flatulence
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
flu like symptoms
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Skin and subcutaneous tissue disorders
flushing
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
gastritis
|
4.1%
2/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
GI disorders- other
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Musculoskeletal and connective tissue disorders
generalized muscle weakness
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Nervous system disorders
headache
|
14.3%
7/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Cardiac disorders
hiccups
|
4.1%
2/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Metabolism and nutrition disorders
hyperglycemia
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Metabolism and nutrition disorders
hyperuricemia
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Metabolism and nutrition disorders
hypokalemia
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Cardiac disorders
hypotension
|
4.1%
2/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Infections and infestations
infections other
|
14.3%
7/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
General disorders
insomnia
|
6.1%
3/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Reproductive system and breast disorders
irregular menstruation
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Musculoskeletal and connective tissue disorders
kyphosis
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Blood and lymphatic system disorders
leukocytosis
|
6.1%
3/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Infections and infestations
lip infection
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Infections and infestations
lung infection
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Blood and lymphatic system disorders
lymphocyte count decrease
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Nervous system disorders
memory impairment
|
20.4%
10/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Infections and infestations
mucosal infection
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
musositis oral
|
22.4%
11/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
|
Gastrointestinal disorders
muculoskeletal and connective tissue disorder - other
|
2.0%
1/49 • Adverse event reporting per patient done beginning at the start intervention per protocol through 30 days post intervention completion, up to 10 years
|
Additional Information
Dr. Felipe Samaniego, MD-Professor, Lymphoma-Myeloma
UT MD Anderson Cancer Center
Phone: (713) 745-6824
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place