Trial Outcomes & Findings for Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myeloma (NCT NCT02603887)
NCT ID: NCT02603887
Last Updated: 2026-01-29
Results Overview
Overall response rate is defined as patients who have achieved partial response or higher as described per IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab. Will be measured according to International Myeloma Working Group Criteria (IMWG) criteria. Response rate will be estimated accordingly. Each cycle has a duration of 21 days.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
EARLY_PHASE1
Target enrollment
20 participants
Primary outcome timeframe
From cycle 1 to cycle 8, up to 168 days
Results posted on
2026-01-29
Participant Flow
Enrollment period was between July 2016 and August 2017
20 participants were consented. 13 participants were treated at MD Anderson Cancer Center. An additional participant started stage 2 that did not participate in Stage 1"
Participant milestones
| Measure |
Treatment (Pembrolizumab)
Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
|
|---|---|
|
Stage 1
STARTED
|
12
|
|
Stage 1
Cycle 1
|
12
|
|
Stage 1
Cycle 8
|
7
|
|
Stage 1
COMPLETED
|
7
|
|
Stage 1
NOT COMPLETED
|
5
|
|
Stage 2
STARTED
|
1
|
|
Stage 2
Cycle 1
|
1
|
|
Stage 2
Cycle 8
|
0
|
|
Stage 2
COMPLETED
|
0
|
|
Stage 2
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Pembrolizumab)
Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
|
|---|---|
|
Stage 1
Adverse Event
|
4
|
|
Stage 1
Disease progression
|
1
|
|
Stage 2
FDA guidance
|
1
|
Baseline Characteristics
Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab)
n=13 Participants
Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=35 Participants
|
|
Age, Continuous
|
68 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=35 Participants
|
|
Myeloma related labs
Hemoglobin
|
12.4 gm/dL
n=35 Participants
|
|
Myeloma related labs
Serum paraprotein
|
1.9 gm/dL
n=35 Participants
|
|
Myeloma related labs
Calcium
|
9.3 mg/dL
n=35 Participants
|
|
Myeloma related labs
Creatinine
|
.88 mg/dL
n=35 Participants
|
|
Myeloma related labs
B2 microglobulin
|
1.9 mg/L
n=35 Participants
|
|
Myeloma related labs
Kappa free light chain
|
127.04 mg/L
n=35 Participants
|
|
Myeloma related labs
Lambda free light chain
|
8.08 mg/L
n=35 Participants
|
|
Myeloma related lab Lactate dehydrogenase
|
439 u/L
n=35 Participants
|
|
Myeloma related lab Bone marrow biopsy plasma cells
|
30 percentage of plasma cells
n=35 Participants
|
|
Myeloma related lab Bence Jones urine protein
|
6 mg/day
n=35 Participants
|
|
Myeloma related labs
Free Light Chains (FLCs) ratio
|
12.27 ratio
n=35 Participants
|
|
Myeloma related labs
Involved:Uninvolved ratio
|
17.95 ratio
n=35 Participants
|
PRIMARY outcome
Timeframe: From cycle 1 to cycle 8, up to 168 daysOverall response rate is defined as patients who have achieved partial response or higher as described per IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab. Will be measured according to International Myeloma Working Group Criteria (IMWG) criteria. Response rate will be estimated accordingly. Each cycle has a duration of 21 days.
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=13 Participants
Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
|
|---|---|
|
Overall Response Rate (ORR)
|
1 Participants
|
SECONDARY outcome
Timeframe: At 30 months from study entryProgressive disease assessed by IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab.
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=13 Participants
Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
|
|---|---|
|
Number of Participants That Had Progression to Multiple Myeloma
|
3 Participants
|
SECONDARY outcome
Timeframe: From cycle 1 to cycle 8, up to 168 daysPopulation: Clinical benefit rate is described as minor response or better assessed by IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab. 1 participant of 13 achieved sCR
Minor response or better assessed by IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=13 Participants
Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
|
|---|---|
|
Clinical Benefit Rate
|
1 Participants
|
SECONDARY outcome
Timeframe: Time of start of treatment to death from any cause up to 2 years and 6 monthsParticipants in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=13 Participants
Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
|
|---|---|
|
Overall Survival
|
12 Participants
|
Adverse Events
Single Arm, Intermediate-high Risk SMM Participants
Serious events: 3 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Single Arm, Intermediate-high Risk SMM Participants
n=13 participants at risk
Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
|
|---|---|
|
Hepatobiliary disorders
Transaminitis
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Renal and urinary disorders
Acute kidney injury
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
Other adverse events
| Measure |
Single Arm, Intermediate-high Risk SMM Participants
n=13 participants at risk
Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Alanine aminotranferase increased
|
23.1%
3/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Anemia
|
38.5%
5/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Gastrointestinal disorders
Anorexia
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increased
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Immune system disorders
Autoimmune disorder
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Eye disorders
Blurred vision
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial infection
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
General disorders
Chills
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Gastrointestinal disorders
Constipation
|
38.5%
5/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Creatinine increased
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Gastrointestinal disorders
Diarrhea
|
46.2%
6/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Ear and labyrinth disorders
Dizziness
|
23.1%
3/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Eye disorders
Dry eye
|
23.1%
3/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Skin and subcutaneous tissue disorders
Edema limbs
|
30.8%
4/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
23.1%
3/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
General disorders
Epistaxis
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Eye disorders
Eye disorders - Other, specify
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Eye disorders
Eye pain
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
General disorders
Fatigue
|
76.9%
10/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
General disorders
Fever
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
General disorders
Headache
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Renal and urinary disorders
Hematuria
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Gastrointestinal disorders
Hepatobiliary disorders - Other, specify
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
General disorders
Hot flashes
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
46.2%
6/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Hyperuricemia
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
30.8%
4/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Hyponatremia
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
General disorders
Insomnia
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Lipase increased
|
23.1%
3/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
General disorders
Memory impairment
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Metabolism and nutrition disorders
Metabolism and nutrition - Other, specify
|
30.8%
4/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
General disorders
Mucositis oral
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Musculoskeletal and connective tissue disorders
Muscoloeskeletal and connective tissue disorder - Other, specify
|
23.1%
3/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.8%
4/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Musculoskeletal and connective tissue disorders
Neck edema
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm benign, malignant and unspecified (incl cyst and polyps) - Other, specify
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
General disorders
Pain
|
30.8%
4/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Cardiac disorders
Palpitations
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Eye disorders
Photophobia
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Infections and infestations
Prostate infection
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.8%
4/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
38.5%
5/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
23.1%
3/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Respiratory, thoracic and mediastinal disorders
Serum amylase increased
|
23.1%
3/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
23.1%
3/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Ear and labyrinth disorders
Tinnutis
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Hepatobiliary disorders
Transaminitis
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Nervous system disorders
Tremor
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
23.1%
3/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Renal and urinary disorders
Urinary frequency
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Renal and urinary disorders
Urinary tract infection
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Renal and urinary disorders
Urinary tract pain
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Renal and urinary disorders
Urinary urgency
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Metabolism and nutrition disorders
Weight loss
|
15.4%
2/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
1/13 • From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
|
Additional Information
Dr. Elisabet Manasanch/ Assistant Professor, Lymphoma-Myeloma
UT MD Anderson Cancer Center
Phone: 713-745-8092
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place