Trial Outcomes & Findings for Leflunomide in Treating Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT02509052)
NCT ID: NCT02509052
Last Updated: 2023-10-10
Results Overview
Observed toxicities will be summarized, for all dose levels, in terms of type (organ affected or laboratory determination), severity, time of onset, duration, serum concentration of the active leflunomide metabolite, probable association with the study treatment and reversibility or outcome.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
28 days
Results posted on
2023-10-10
Participant Flow
The protocol was formerly designed as a Phase I/II trial. New preclinical trial data were cause for us to conclude the trial before beginning the phase II portion.
Participant milestones
| Measure |
Arm 1: 20 mg Leflunomide
Patients receive 20 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2: 40 mg Leflunomide
Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 3: 60 mg Leflunomide
Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm 1: 20 mg Leflunomide
Patients receive 20 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2: 40 mg Leflunomide
Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 3: 60 mg Leflunomide
Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
Non compliance
|
0
|
0
|
1
|
Baseline Characteristics
This is division of the Positive patients.
Baseline characteristics by cohort
| Measure |
Arm 1: 20 mg Leflunomide
n=3 Participants
Patients receive 20 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2: 40 mg Leflunomide
n=3 Participants
Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 3: 60 mg Leflunomide
n=6 Participants
Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
62 years
n=7 Participants
|
71 years
n=5 Participants
|
68 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
race/ethnicity · Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
race/ethnicity · Black
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
race/ethnicity · Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
race/ethnicity · White, non-Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
ISS staging at diagnosis
Stage I
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
ISS staging at diagnosis
Stage II
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
ISS staging at diagnosis
Stage III
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
ISS staging at diagnosis
Unknown/missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Prior autologous transplant
Yes
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Prior autologous transplant
No
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Prior radiation
Yes
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Prior radiation
No
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Serum electrophoresis and immunofixation
Positive
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Serum electrophoresis and immunofixation
Negative
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Type of positive serum electrophoresis and immunofixation patients
IgG kappa
|
1 Participants
n=5 Participants • This is division of the Positive patients.
|
1 Participants
n=7 Participants • This is division of the Positive patients.
|
3 Participants
n=5 Participants • This is division of the Positive patients.
|
5 Participants
n=4 Participants • This is division of the Positive patients.
|
|
Type of positive serum electrophoresis and immunofixation patients
IgG lambda
|
0 Participants
n=5 Participants • This is division of the Positive patients.
|
1 Participants
n=7 Participants • This is division of the Positive patients.
|
2 Participants
n=5 Participants • This is division of the Positive patients.
|
3 Participants
n=4 Participants • This is division of the Positive patients.
|
|
Type of positive serum electrophoresis and immunofixation patients
IgA lambda
|
0 Participants
n=5 Participants • This is division of the Positive patients.
|
0 Participants
n=7 Participants • This is division of the Positive patients.
|
0 Participants
n=5 Participants • This is division of the Positive patients.
|
0 Participants
n=4 Participants • This is division of the Positive patients.
|
|
Type of positive serum electrophoresis and immunofixation patients
Serum unknown
|
1 Participants
n=5 Participants • This is division of the Positive patients.
|
0 Participants
n=7 Participants • This is division of the Positive patients.
|
1 Participants
n=5 Participants • This is division of the Positive patients.
|
2 Participants
n=4 Participants • This is division of the Positive patients.
|
|
Type of positive serum electrophoresis and immunofixation patients
IgA kappa
|
1 Participants
n=5 Participants • This is division of the Positive patients.
|
1 Participants
n=7 Participants • This is division of the Positive patients.
|
0 Participants
n=5 Participants • This is division of the Positive patients.
|
2 Participants
n=4 Participants • This is division of the Positive patients.
|
|
PI refractory
Yes
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
PI refractory
No
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
IMiD refractory
Yes
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
IMiD refractory
No
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Double refractory (bortezomib/lenalidomide)
Yes
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Double refractory (bortezomib/lenalidomide)
No
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Recommended phase 2 dose: This was the highest planned dose level within this study. Because we obtained preclinical data indicating a synergistic effect between leflunomide and lenalidomide, we determined that investigating leflunomide-based combinational therapy was favorable over pursuing a phase 2 study of single-agent leflunomide. There were no dose de-escalations, so there were no patients accrued to the arms for 10mg, 30mg, or 50mg.
Observed toxicities will be summarized, for all dose levels, in terms of type (organ affected or laboratory determination), severity, time of onset, duration, serum concentration of the active leflunomide metabolite, probable association with the study treatment and reversibility or outcome.
Outcome measures
| Measure |
All Participants
n=12 Participants
Patients receive 20, 40 or 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2: 40 mg Leflunomide
Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 3: 60 mg Leflunomide
Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
MTD, Defined as the Highest Dose in Which =< 1/6 Patients Experience a Dose-limiting Toxicity, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03
|
60 mg
|
—
|
—
|
PRIMARY outcome
Timeframe: From the start of treatment until disease progression/recurrence, assessed up to 48 monthsPopulation: Because we obtained preclinical data indicating a synergistic effect between leflunomide and lenalidomide, we determined that investigating leflunomide-based combinational therapy was favorable over pursuing a phase 2 study of single-agent leflunomide. There were no dose de-escalations, so there were no patients accrued to the arms for 10mg, 30mg, or 50mg.
Stringent complete response \[sCR\]/complete response \[CR\]/very good partial response \[VGPR\]/or partial response \[PR\]), assessed by International Myeloma Working Group (IMWG) criteria.
Outcome measures
| Measure |
All Participants
n=3 Participants
Patients receive 20, 40 or 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2: 40 mg Leflunomide
n=3 Participants
Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 3: 60 mg Leflunomide
n=5 Participants
Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Best Overall Response Rate: Proportion of Patients Reaching CR by IMWG Criteria
|
3 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment until disease progression/recurrence, assessed up to 48 monthsPopulation: Evaluable patients. One patient was non-compliant, therefore, inevaluable. Because we obtained preclinical data indicating a synergistic effect between leflunomide and lenalidomide, we determined that investigating leflunomide-based combinational therapy was favorable over pursuing a phase 2 study of single-agent leflunomide. There were no dose de-escalations, so there were no patients accrued to the arms for 10mg, 30mg, or 50mg.
Clinical benefit response rate (sCR/CR/VGPR/partial response \[PR\]/minimal response \[MR\] or stable disease \[SD\]), assessed by International Myeloma Working Group (IMWG) criteria
Outcome measures
| Measure |
All Participants
n=3 Participants
Patients receive 20, 40 or 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2: 40 mg Leflunomide
n=3 Participants
Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 3: 60 mg Leflunomide
n=5 Participants
Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Clinical Benefit Response Rate (sCR/CR/VGPR/Partial Response [PR]/Minimal Response [MR] or Stable Disease [SD]), Assessed by IMWG Criteria
|
3 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Assessed up to 48 monthsPopulation: Among the 12 enrolled patients, only 11 patients are evaluable for response. And 9 of the 11 evaluable patients reached CR. The response duration is based on these 9 CR patients.
Median and range of nine patients with Complete Response (CR)
Outcome measures
| Measure |
All Participants
n=3 Participants
Patients receive 20, 40 or 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2: 40 mg Leflunomide
n=3 Participants
Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 3: 60 mg Leflunomide
n=3 Participants
Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Response Duration
|
336 days
Interval 28.0 to 401.0
|
112 days
Interval 91.0 to 152.0
|
54 days
Interval 28.0 to 56.0
|
SECONDARY outcome
Timeframe: Assessed at ninety days.Population: Nine patients who reached CR among 11 patients evaluable for response. Because we obtained preclinical data indicating a synergistic effect between leflunomide and lenalidomide, we determined that investigating leflunomide-based combinational therapy was favorable over pursuing a phase 2 study of single-agent leflunomide. There were no dose de-escalations, so there were no patients accrued to the arms for 10mg, 30mg, or 50mg.
Number of patients with Stable Disease greater than or equal to 90 days
Outcome measures
| Measure |
All Participants
n=3 Participants
Patients receive 20, 40 or 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2: 40 mg Leflunomide
n=3 Participants
Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 3: 60 mg Leflunomide
n=3 Participants
Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Response Duration
|
2 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
Arm 1: 20 mg Leflunomide
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2: 40 mg Leflunomide
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Arm 3: 60 mg Leflunomide
Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm 1: 20 mg Leflunomide
n=3 participants at risk
Patients receive 20 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2: 40 mg Leflunomide
n=3 participants at risk
Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 3: 60 mg Leflunomide
n=6 participants at risk
Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
General disorders
10016558-Fever
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Infections and infestations
10040047-Sepsis
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Infections and infestations
10046571-Urinary tract infection
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Infections and infestations
10061229-Lung infection
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Injury, poisoning and procedural complications
10017076-Fracture
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Investigations
10003481-Aspartate aminotransferase increased
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
10003988-Back pain
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
10023838-Laryngeal edema
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
Other adverse events
| Measure |
Arm 1: 20 mg Leflunomide
n=3 participants at risk
Patients receive 20 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2: 40 mg Leflunomide
n=3 participants at risk
Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm 3: 60 mg Leflunomide
n=6 participants at risk
Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
10002272-Anemia
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Blood and lymphatic system disorders
10025182-Lymph node pain
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Cardiac disorders
10033557-Palpitations
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Cardiac disorders
10040752-Sinus tachycardia
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
50.0%
3/6 • up to thirty days post-treatment.
|
|
Cardiac disorders
10061389-Tricuspid valve disease
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Cardiac disorders
10061589-Aortic valve disease
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Ear and labyrinth disorders
10014020-Ear pain
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Eye disorders
10005886-Blurred vision
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Eye disorders
10034960-Photophobia
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Gastrointestinal disorders
10000081-Abdominal pain
|
66.7%
2/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Gastrointestinal disorders
10008417-Cheilitis
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Gastrointestinal disorders
10010774-Constipation
|
0.00%
0/3 • up to thirty days post-treatment.
|
66.7%
2/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Gastrointestinal disorders
10012727-Diarrhea
|
66.7%
2/3 • up to thirty days post-treatment.
|
66.7%
2/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Gastrointestinal disorders
10028813-Nausea
|
33.3%
1/3 • up to thirty days post-treatment.
|
66.7%
2/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Gastrointestinal disorders
10044055-Toothache
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Gastrointestinal disorders
10047700-Vomiting
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
General disorders
10008531-Chills
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
General disorders
10014222-Edema face
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
General disorders
10016059-Facial pain
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
General disorders
10016256-Fatigue
|
66.7%
2/3 • up to thirty days post-treatment.
|
100.0%
3/3 • up to thirty days post-treatment.
|
66.7%
4/6 • up to thirty days post-treatment.
|
|
General disorders
10016558-Fever
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
50.0%
3/6 • up to thirty days post-treatment.
|
|
General disorders
10017577-Gait disturbance
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
General disorders
10025482-Malaise
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
General disorders
10033371-Pain
|
0.00%
0/3 • up to thirty days post-treatment.
|
66.7%
2/3 • up to thirty days post-treatment.
|
50.0%
3/6 • up to thirty days post-treatment.
|
|
General disorders
10054482-Neck edema
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
General disorders
10062466-Localized edema
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
General disorders
10062501-Non-cardiac chest pain
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Infections and infestations
10040872-Skin infection
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Infections and infestations
10046300-Upper respiratory infection
|
33.3%
1/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Infections and infestations
10046571-Urinary tract infection
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
50.0%
3/6 • up to thirty days post-treatment.
|
|
Injury, poisoning and procedural complications
10016173-Fall
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Investigations
10001551-Alanine aminotransferase increased
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Investigations
10003481-Aspartate aminotransferase increased
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Investigations
10005364-Blood bilirubin increased
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Investigations
10011368-Creatinine increased
|
0.00%
0/3 • up to thirty days post-treatment.
|
66.7%
2/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Investigations
10025256-Lymphocyte count decreased
|
33.3%
1/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Investigations
10029366-Neutrophil count decreased
|
100.0%
3/3 • up to thirty days post-treatment.
|
100.0%
3/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Investigations
10035528-Platelet count decreased
|
66.7%
2/3 • up to thirty days post-treatment.
|
100.0%
3/3 • up to thirty days post-treatment.
|
83.3%
5/6 • up to thirty days post-treatment.
|
|
Investigations
10047896-Weight gain
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Investigations
10047900-Weight loss
|
33.3%
1/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Investigations
10049182-White blood cell decreased
|
100.0%
3/3 • up to thirty days post-treatment.
|
100.0%
3/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10002646-Anorexia
|
33.3%
1/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
66.7%
4/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10012174-Dehydration
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10020587-Hypercalcemia
|
33.3%
1/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10020639-Hyperglycemia
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10020670-Hypermagnesemia
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10020870-Hypertriglyceridemia
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10020907-Hyperuricemia
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10020943-Hypoalbuminemia
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
50.0%
3/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10020949-Hypocalcemia
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10021005-Hypoglycemia
|
33.3%
1/3 • up to thirty days post-treatment.
|
66.7%
2/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10021018-Hypokalemia
|
0.00%
0/3 • up to thirty days post-treatment.
|
100.0%
3/3 • up to thirty days post-treatment.
|
50.0%
3/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10021028-Hypomagnesemia
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10021038-Hyponatremia
|
66.7%
2/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
50.0%
3/6 • up to thirty days post-treatment.
|
|
Metabolism and nutrition disorders
10021059-Hypophosphatemia
|
66.7%
2/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
10003239-Arthralgia
|
66.7%
2/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
10003988-Back pain
|
33.3%
1/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
10006002-Bone pain
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
10016750-Flank pain
|
0.00%
0/3 • up to thirty days post-treatment.
|
66.7%
2/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
10028411-Myalgia
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
50.0%
3/6 • up to thirty days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
10028836-Neck pain
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
10033425-Pain in extremity
|
33.3%
1/3 • up to thirty days post-treatment.
|
66.7%
2/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
10039722-Scoliosis
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
10062572-Generalized muscle weakness
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10029104-Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Nervous system disorders
10013573-Dizziness
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Nervous system disorders
10019211-Headache
|
33.3%
1/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Nervous system disorders
10041349-Somnolence
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Psychiatric disorders
10002855-Anxiety
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Psychiatric disorders
10010300-Confusion
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Psychiatric disorders
10022437-Insomnia
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Renal and urinary disorders
10019450-Hematuria
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Renal and urinary disorders
10037032-Proteinuria
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Renal and urinary disorders
10046539-Urinary frequency
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Reproductive system and breast disorders
10046912-Vaginal hemorrhage
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
10001723-Allergic rhinitis
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
10011224-Cough
|
66.7%
2/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
10013963-Dyspnea
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
10028735-Nasal congestion
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
10035623-Pleuritic pain
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
10037400-Pulmonary hypertension
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
10038738-Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
10041367-Sore throat
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
1/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Skin and subcutaneous tissue disorders
10020642-Hyperhidrosis
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
16.7%
1/6 • up to thirty days post-treatment.
|
|
Vascular disorders
10020407-Hot flashes
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
0.00%
0/6 • up to thirty days post-treatment.
|
|
Vascular disorders
10020772-Hypertension
|
100.0%
3/3 • up to thirty days post-treatment.
|
66.7%
2/3 • up to thirty days post-treatment.
|
83.3%
5/6 • up to thirty days post-treatment.
|
|
Vascular disorders
10021097-Hypotension
|
33.3%
1/3 • up to thirty days post-treatment.
|
0.00%
0/3 • up to thirty days post-treatment.
|
33.3%
2/6 • up to thirty days post-treatment.
|
Additional Information
Michael Rosenzweig, MD
Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope, Duarte, CA 91010
Phone: 626-218-2405
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place