Trial Outcomes & Findings for Sunitinib in Treating Patients With Relapsed Multiple Myeloma (NCT NCT00514137)
NCT ID: NCT00514137
Last Updated: 2014-05-28
Results Overview
A confirmed response is defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 2 weeks apart. A Complete Response (CR) is defined as the complete disappearance of an M-protein and fewer than 5% bone marrow plasmacytosis. A Hematologic Very good partial response (VGPR) is defined as having a ≥ 90% reduction of M-protein from serum, a Urine M-spike to be ≤ 100 mg/24 hours, and a disappearance of soft tissue plasmacytomas. A Partial Response (PR) is defined as having a 50-89% reduction in the level of the serum monoclonal protein, a reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg, and a ≥ 50% reduction in size of soft tissue plasmacytoma.
COMPLETED
PHASE2
13 participants
Every 6 weeks from the first initiation of therapy up to 72 weeks
2014-05-28
Participant Flow
Thirteen participants were accrued from September 2007 to December 2008.
All 13 participants were analyzed.
Participant milestones
| Measure |
Treatment (Kinase Inhibitor Therapy)
Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sunitinib in Treating Patients With Relapsed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Treatment (Kinase Inhibitor Therapy)
n=13 Participants
Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks from the first initiation of therapy up to 72 weeksPopulation: All 13 participants were evaluable for a response
A confirmed response is defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 2 weeks apart. A Complete Response (CR) is defined as the complete disappearance of an M-protein and fewer than 5% bone marrow plasmacytosis. A Hematologic Very good partial response (VGPR) is defined as having a ≥ 90% reduction of M-protein from serum, a Urine M-spike to be ≤ 100 mg/24 hours, and a disappearance of soft tissue plasmacytomas. A Partial Response (PR) is defined as having a 50-89% reduction in the level of the serum monoclonal protein, a reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg, and a ≥ 50% reduction in size of soft tissue plasmacytoma.
Outcome measures
| Measure |
Treatment (Kinase Inhibitor Therapy)
n=13 Participants
Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
The Number of Confirmed Responses (Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR])
|
0 participants
|
SECONDARY outcome
Timeframe: Time from registration to progression or death due to any cause, assessed up to 3 yearsThe distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Kinase Inhibitor Therapy)
n=13 Participants
Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Event-free Survival
|
2.86 months
Interval 1.35 to 5.52
|
SECONDARY outcome
Timeframe: From the documentation of response until the date of progressionPopulation: No analysis was done because there were no confirmed responses.
The distribution of duration of response will be estimated using the method of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the time of first treatment to up to 30 days after the last day of study drug treatmentAssessed per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Included are the toxicities at least possibly related to the study drug.
Outcome measures
| Measure |
Treatment (Kinase Inhibitor Therapy)
n=13 Participants
Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Toxicity
Grade 3+ Adverse Events
|
10 participants
|
|
Toxicity
Grade 4+ Adverse Events
|
3 participants
|
|
Toxicity
Grade 5 Adverse Events
|
0 participants
|
Adverse Events
Treatment (Kinase Inhibitor Therapy)
Serious adverse events
| Measure |
Treatment (Kinase Inhibitor Therapy)
n=13 participants at risk
Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
15.4%
2/13 • Number of events 2
|
|
Cardiac disorders
Left ventricular dysfunction
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Creatinine increased
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
15.4%
2/13 • Number of events 2
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
Protein urine positive
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Kinase Inhibitor Therapy)
n=13 participants at risk
Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
61.5%
8/13 • Number of events 9
|
|
Endocrine disorders
Hypothyroidism
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
46.2%
6/13 • Number of events 8
|
|
Gastrointestinal disorders
Dyspepsia
|
30.8%
4/13 • Number of events 6
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
38.5%
5/13 • Number of events 6
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
38.5%
5/13 • Number of events 5
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Edema limbs
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Fatigue
|
84.6%
11/13 • Number of events 19
|
|
General disorders
Fever
|
15.4%
2/13 • Number of events 2
|
|
Investigations
Amylase increased
|
15.4%
2/13 • Number of events 3
|
|
Investigations
Leukocyte count decreased
|
69.2%
9/13 • Number of events 11
|
|
Investigations
Lipase increased
|
15.4%
2/13 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
53.8%
7/13 • Number of events 10
|
|
Investigations
Platelet count decreased
|
76.9%
10/13 • Number of events 14
|
|
Investigations
Weight loss
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
53.8%
7/13 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
15.4%
2/13 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Taste alteration
|
38.5%
5/13 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
46.2%
6/13 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
15.4%
2/13 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
23.1%
3/13 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
7.7%
1/13 • Number of events 3
|
|
Vascular disorders
Hypertension
|
30.8%
4/13 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60