Trial Outcomes & Findings for Dinaciclib in Treating Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT01096342)
NCT ID: NCT01096342
Last Updated: 2014-06-18
Results Overview
Complete Response (CR): Negative immunofixation of serum and urine Normalization of FLC ratio \< 5% plasma cells in bone marrow Disappearance of any soft tissue plasmacytomas Stringent Complete Response (sCR): CR, as above, with absence of clonal cells in bone marrow Partial Response (PR): One of the following: 1. A ≥ 50% reduction of measurable serum M-protein. 2. A reduction in 24h measurable urinary M-protein by ≥ 90% or to \<200 mg per 24h. 3. A ≥ 50% decrease in the difference between involved and uninvolved FLC levels. 4. ≥50% reduction in bone marrow plasma cells is required in place of Mprotein, provided baseline percentage was ≥ 30% 5. A ≥50% reduction in the size of soft tissue plasmacytomas. Very Good Partial Response (VGPR): PR as defined above in addition to having serum and urine M-component detectable by immunofixation but not on electrophoresis.
COMPLETED
PHASE2
16 participants
Up to 3 years
2014-06-18
Participant Flow
From 7/2009 to 12/2011, 29 participants were accrued. The study opened at 50 mg/m\^2, accrued 2, and closed for safety review and protocol amendment. The study reopened with a dose escalation phase and accrued 4 at 30 mg/m\^2 dose, 7 at 40 mg/m\^2 dose, and 6 at 50 mg/m\^2 dose. The Phase II dose level was set at 50 mg/m\^2 and accrued 10 participants.
Of the 10 participants accrued in the Phase II portion of the study, one was excluded for protocol violation. The 6 participants treated in the Safety Analysis Phase at the 50 mg/m\^2 dose level (after the protocol amendment) are included in the Phase II analysis. Therefore, this Phase II analysis is based on 15 evaluable participants.
Participant milestones
| Measure |
Phase II: 50 mg/m^2
Participants were accrued at 50 mg/m\^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m\^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Phase II: 50 mg/m^2
Participants were accrued at 50 mg/m\^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m\^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Dinaciclib in Treating Patients With Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Phase II
n=15 Participants
Participants were accrued at 50 mg/m\^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m\^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
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Age, Continuous
|
64 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
|
Region of Enrollment
Singapore
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Fifteen of the 16 accrued Phase II participants were analyzed (1 participant was a protocol violation).
Complete Response (CR): Negative immunofixation of serum and urine Normalization of FLC ratio \< 5% plasma cells in bone marrow Disappearance of any soft tissue plasmacytomas Stringent Complete Response (sCR): CR, as above, with absence of clonal cells in bone marrow Partial Response (PR): One of the following: 1. A ≥ 50% reduction of measurable serum M-protein. 2. A reduction in 24h measurable urinary M-protein by ≥ 90% or to \<200 mg per 24h. 3. A ≥ 50% decrease in the difference between involved and uninvolved FLC levels. 4. ≥50% reduction in bone marrow plasma cells is required in place of Mprotein, provided baseline percentage was ≥ 30% 5. A ≥50% reduction in the size of soft tissue plasmacytomas. Very Good Partial Response (VGPR): PR as defined above in addition to having serum and urine M-component detectable by immunofixation but not on electrophoresis.
Outcome measures
| Measure |
Phase II
n=15 Participants
Participants were accrued at 50 mg/m\^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m\^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Confirmed Responses, Defined to be an sCR, CR, VGPR, or PR Noted as the Objective Status on Two Consecutive Evaluations.
Complete Response (CR)
|
0 participants
|
|
Number of Confirmed Responses, Defined to be an sCR, CR, VGPR, or PR Noted as the Objective Status on Two Consecutive Evaluations.
Stringent Complete Response (sCR)
|
0 participants
|
|
Number of Confirmed Responses, Defined to be an sCR, CR, VGPR, or PR Noted as the Objective Status on Two Consecutive Evaluations.
Very Good Partial Response (VGPR)
|
0 participants
|
|
Number of Confirmed Responses, Defined to be an sCR, CR, VGPR, or PR Noted as the Objective Status on Two Consecutive Evaluations.
Partial Response (PR)
|
0 participants
|
SECONDARY outcome
Timeframe: Time from registration to progression or death due to any cause, assessed up to 3 yearsPopulation: All 15 evaluable participants were analyzed for Progression-Free Survival.
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Phase II
n=15 Participants
Participants were accrued at 50 mg/m\^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m\^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
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Progression-free Survival
|
2.73 months
Interval 0.69 to 5.52
|
SECONDARY outcome
Timeframe: Date at which the patient's objective status is first noted to be either an sCR, CR, PR, or VGPR to the earliest date progression is documented, assessed up to 3 yearsPopulation: Duration of Response was not analyzed due to lack of responses.
The distribution of duration of response will be estimated using the method of Kaplan-Meier.
Outcome measures
Outcome data not reported
Adverse Events
Phase II: 50 mg/m^2
Serious adverse events
| Measure |
Phase II: 50 mg/m^2
n=15 participants at risk
Participants were accrued at 50 mg/m\^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m\^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
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Eye disorders
Dry eye syndrome
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Eye pain
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Photophobia
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Vision blurred
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Platelet count decreased
|
13.3%
2/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 1
|
Other adverse events
| Measure |
Phase II: 50 mg/m^2
n=15 participants at risk
Participants were accrued at 50 mg/m\^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m\^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
6.7%
1/15 • Number of events 3
|
|
Eye disorders
Vision blurred
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
80.0%
12/15 • Number of events 28
|
|
Gastrointestinal disorders
Nausea
|
60.0%
9/15 • Number of events 19
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
6/15 • Number of events 8
|
|
General disorders
Fatigue
|
93.3%
14/15 • Number of events 27
|
|
General disorders
Fever
|
20.0%
3/15 • Number of events 3
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 2
|
|
Infections and infestations
Peripheral nerve infection
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
6.7%
1/15 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
5/15 • Number of events 8
|
|
Investigations
Aspartate aminotransferase increased
|
46.7%
7/15 • Number of events 18
|
|
Investigations
Bilirubin increased
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
40.0%
6/15 • Number of events 9
|
|
Investigations
Lymphocyte count decreased
|
33.3%
5/15 • Number of events 10
|
|
Investigations
Neutrophil count decreased
|
26.7%
4/15 • Number of events 5
|
|
Investigations
Platelet count decreased
|
73.3%
11/15 • Number of events 19
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.7%
1/15 • Number of events 3
|
|
Nervous system disorders
Peripheral motor neuropathy
|
13.3%
2/15 • Number of events 11
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
40.0%
6/15 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
2/15 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
5/15 • Number of events 6
|
|
Vascular disorders
Hypotension
|
20.0%
3/15 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60