Trial Outcomes & Findings for Pom-dex Versus Pom-Cyclo-dex in MM Patients With Biochemical or Clinical Relapse, During Lena Maintenance Treatment (NCT NCT03440411)
NCT ID: NCT03440411
Last Updated: 2021-03-10
Results Overview
defined as the time from the date of random disclosure to the date of death from any cause for the comparisons B vs A
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
9 participants
Primary outcome timeframe
57 months
Results posted on
2021-03-10
Participant Flow
At enrollment patients was randomized to receive Late (II) vs Early (I) treatment and Pom-Cyclo-dex (B) vs Pom-dex (A) at the same time. If patient was randomized to receive I treatment, the result of the comparison between BvsA was immediately available. Otherwise, in case of II treatment the random disclosure of the comparison between B vs A arm was at the confirmation of CRAB. Patients was randomized using blocks of sizes 12 by the electronic Case Report Form.
For previous reason 1pt randomized to Late (II) treatment who not achieved a CRAB has not the disclosure of the randomization between A vs B arm.
Participant milestones
| Measure |
ARM Pom-dex Early (A-I)
Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-dex Late (A-II)
Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-cyclo-dex Early (B-I)
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-cyclo-dex Late (B-II)
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
ARM Pom-dex Early (A-I)
Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-dex Late (A-II)
Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-cyclo-dex Early (B-I)
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-cyclo-dex Late (B-II)
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
PD
|
2
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Closed study by sponsor
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Pom-dex Versus Pom-Cyclo-dex in MM Patients With Biochemical or Clinical Relapse, During Lena Maintenance Treatment
Baseline characteristics by cohort
| Measure |
ARM Pom-dex Early (A-I)
n=3 Participants
Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-dex Late (A-II)
n=1 Participants
Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-cyclo-dex Early (B-I)
n=2 Participants
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-cyclo-dex Late (B-II)
n=2 Participants
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Age, Continuous
|
54 years
n=5 Participants
|
68 years
n=7 Participants
|
59.5 years
n=5 Participants
|
60 years
n=4 Participants
|
60 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
8 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
isotype
IgG
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
isotype
Bj
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
International Staging System (ISS) Stage
I
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
International Staging System (ISS) Stage
II
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Previous Therapies (induction/Autologous Stem Cell Transplantation/consolidation)
ASCT
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Previous Therapies (induction/Autologous Stem Cell Transplantation/consolidation)
Len
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Previous Therapies (induction/Autologous Stem Cell Transplantation/consolidation)
Bort
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 57 monthsPopulation: This analysis included only patients in whom CPd vs Pd randomization was disclosed.
defined as the time from the date of random disclosure to the date of death from any cause for the comparisons B vs A
Outcome measures
| Measure |
Arm A
n=4 Participants
Pd
|
Arm B
n=4 Participants
CPd
|
ARM B-I
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM B-II
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
|---|---|---|---|---|
|
Overall Survival (OS)
Death
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Overall Survival (OS)
Censored
|
2 Participants
|
4 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 57 monthsPopulation: This analysis included only patients in whom CPd vs Pd randomization was disclosed.
defined as the time from the date of random disclosure to the date of death from any cause for the comparisons II vs I
Outcome measures
| Measure |
Arm A
n=5 Participants
Pd
|
Arm B
n=3 Participants
CPd
|
ARM B-I
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM B-II
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
|---|---|---|---|---|
|
Overall Survival
Death
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Overall Survival
Censored
|
4 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 57 monthsPopulation: All population
defined as the time from random assignment to the early or late strategy to the date of onset of CRAB symptoms or death. Clinical relapse requires one or more direct indicators of progressive disease and end organ dysfunction (CRAB features). Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder: * hypercalcaemia * renal insufficiency * anaemia * bone lesions Any one or more of the following biomarkers of malignancy: * clonal bone marrow plasma cell percentage ≥60% * involved:uninvolved serum free light chain ratio ≥100 * \>1 focal lesions on MRI studies (each focal lesion must be 5 mm or more in size) Progresson was defined accoring to IMWG criteria as reported before
Outcome measures
| Measure |
Arm A
n=5 Participants
Pd
|
Arm B
n=4 Participants
CPd
|
ARM B-I
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM B-II
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
|---|---|---|---|---|
|
Clinical Progression
Not evaluable
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Clinical Progression
Without CRAB
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 57 monthsPopulation: ITT
PFS for the comparison B vs A will be measured from the date of randomization disclosure to the date of first observation of PD, or death from any cause as an event. Subjects who have not progressed or who withdraw from the study will be censored at the time of the last complete disease assessment. All subjects who were lost to Follow Up (FU) will also be censored at the time of last complete disease assessment
Outcome measures
| Measure |
Arm A
n=4 Participants
Pd
|
Arm B
n=4 Participants
CPd
|
ARM B-I
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM B-II
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
|---|---|---|---|---|
|
Progression Free-survival (PFS)
Events
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Progression Free-survival (PFS)
Censored
|
1 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 57 monthsPopulation: This analysis included only patients in whom CPd vs Pd randomization was disclosed.
PFS for the comparison II vs I will be measured from the date of randomization disclosure to the date of first observation of PD, or death from any cause as an event. Subjects who have not progressed or who withdraw from the study will be censored at the time of the last complete disease assessment. All subjects who were lost to FU will also be censored at the time of last complete disease assessment
Outcome measures
| Measure |
Arm A
n=5 Participants
Pd
|
Arm B
n=3 Participants
CPd
|
ARM B-I
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM B-II
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
Events
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Progression Free Survival (PFS)
Censored
|
2 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 57 monthsPopulation: ITT
PFS for the comparison B vs A will be measured from the date of randomization disclosure to the date of first observation of PD in second line therapy, or death from any cause as an event. Subjects who have not progressed or who withdraw from the study will be censored at the time of the last complete disease assessment. All subjects who were lost to FU will also be censored at the time of last complete disease assessment
Outcome measures
| Measure |
Arm A
n=4 Participants
Pd
|
Arm B
n=4 Participants
CPd
|
ARM B-I
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM B-II
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
|---|---|---|---|---|
|
Progression Free-survival 2(PFS2)
Events
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Progression Free-survival 2(PFS2)
Censored
|
2 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 57 monthsPopulation: This analysis included only patients in whom CPd vs Pd randomization was disclosed.
PFS for the comparison II vs I will be measured from the date of randomization disclosure to the date of first observation of PD in second line therapy, or death from any cause as an event. Subjects who have not progressed or who withdraw from the study will be censored at the time of the last complete disease assessment. All subjects who were lost to FU will also be censored at the time of last complete disease assessment
Outcome measures
| Measure |
Arm A
n=5 Participants
Pd
|
Arm B
n=3 Participants
CPd
|
ARM B-I
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM B-II
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
|---|---|---|---|---|
|
Progression Free Survival 2(PFS2)
Events
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Progression Free Survival 2(PFS2)
Censored
|
3 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 57 monthsPopulation: ITT
in terms of partial response (PR), very good partial response (VGPR), complete response (CR).and stringent complete response (sCR) according to IMWG response crieria (https://www.myeloma.org/resource-library/international-myeloma-working-group-imwg-uniform-response-criteria-multiple).
Outcome measures
| Measure |
Arm A
n=4 Participants
Pd
|
Arm B
n=4 Participants
CPd
|
ARM B-I
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM B-II
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
|---|---|---|---|---|
|
Objective Overall Response Rate for the Comparison B vs A
VGPR
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Objective Overall Response Rate for the Comparison B vs A
PR
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Objective Overall Response Rate for the Comparison B vs A
SD
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Objective Overall Response Rate for the Comparison B vs A
sCR
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Objective Overall Response Rate for the Comparison B vs A
CR
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Objective Overall Response Rate for the Comparison B vs A
PD
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Objective Overall Response Rate for the Comparison B vs A
NE
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 57 monthsPopulation: ITT
in terms of partial response (PR), very good partial response (VGPR), complete response (CR).and stringent complete response (sCR) according to IMWG response crieria (https://www.myeloma.org/resource-library/international-myeloma-working-group-imwg-uniform-response-criteria-multiple).
Outcome measures
| Measure |
Arm A
n=5 Participants
Pd
|
Arm B
n=3 Participants
CPd
|
ARM B-I
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM B-II
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
|---|---|---|---|---|
|
Objective Overall Response Rate for the Comparison II vs I
PR
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Objective Overall Response Rate for the Comparison II vs I
SD
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Objective Overall Response Rate for the Comparison II vs I
sCR
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Objective Overall Response Rate for the Comparison II vs I
CR
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Objective Overall Response Rate for the Comparison II vs I
VGPR
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Objective Overall Response Rate for the Comparison II vs I
PD
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Objective Overall Response Rate for the Comparison II vs I
NE
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 57 monthsPopulation: data could not be reported in the data table since analysis was not performed according to the lower sample size and QLQ missing
outcome will be measured with EORTC-QLQ-C30 at baseline, every 2 months during the first year, and then every 6 months for the comparison B vs B and I vs II.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 57 monthsPopulation: data could not be reported in the data table since analysis was not performed according to the lower sample size and QLQ missing
outcome will be measured with QLQ-MY24 at baseline, every 2 months during the first year, and then every 6 months for the comparison B vs B and I vs II.
Outcome measures
Outcome data not reported
Adverse Events
ARM Pom-dex Early (A-I)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
ARM Pom-dex Late (A-II)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
ARM Pom-cyclo-dex Early (B-I)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ARM Pom-cyclo-dex Late (B-II)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARM Pom-dex Early (A-I)
n=3 participants at risk
Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-dex Late (A-II)
n=1 participants at risk
Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-cyclo-dex Early (B-I)
n=2 participants at risk
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-cyclo-dex Late (B-II)
n=2 participants at risk
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
|---|---|---|---|---|
|
Renal and urinary disorders
Acute renal failure
|
33.3%
1/3 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
Other adverse events
| Measure |
ARM Pom-dex Early (A-I)
n=3 participants at risk
Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-dex Late (A-II)
n=1 participants at risk
Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-cyclo-dex Early (B-I)
n=2 participants at risk
Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
ARM Pom-cyclo-dex Late (B-II)
n=2 participants at risk
Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
|
|---|---|---|---|---|
|
Psychiatric disorders
Agitation_1
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Psychiatric disorders
Agitation_2
|
33.3%
1/3 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Psychiatric disorders
Agitation_3
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Investigations
ALT increased_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Blood and lymphatic system disorders
Anemia_1
|
33.3%
1/3 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Investigations
AST increased_1
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Infections and infestations
Bronchial infection_2
|
33.3%
1/3 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
General disorders
Chills_1
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
100.0%
1/1 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Psychiatric disorders
Confusion_2
|
33.3%
1/3 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Gastrointestinal disorders
Constipation_1
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
100.0%
1/1 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Gastrointestinal disorders
Diarrhea_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Injury, poisoning and procedural complications
Eye burns_2
|
33.3%
1/3 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
General disorders
Fatigue_1
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
General disorders
Fatigue_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
General disorders
Fatigue_3
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
100.0%
1/1 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
General disorders
Fever_3
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
General disorders
Flu like symptoms_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Infections and infestations
Gastroenteritis_1
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Infections and infestations
Gastroenteritis_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Metabolism and nutrition disorders
Hyperglycemia_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Vascular disorders
Hypertension_1
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Psychiatric disorders
Insomnia_2
|
33.3%
1/3 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Skin and subcutaneous tissue disorders
Leg ulcer_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Infections and infestations
Lung infection_2
|
33.3%
1/3 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Respiratory, thoracic and mediastinal disorders
Lung nodule_3
|
33.3%
1/3 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps_1
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps_3
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness_3
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Blood and lymphatic system disorders
Neutropenia_3
|
33.3%
1/3 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
100.0%
1/1 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 5 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Musculoskeletal and connective tissue disorders
Pain in limb_1
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Musculoskeletal and connective tissue disorders
Pain in limb_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Musculoskeletal and connective tissue disorders
Pain in limb_3
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Nervous system disorders
Peripheral motor neuropathy_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Nervous system disorders
Presyncope_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular_2
|
66.7%
2/3 • Number of events 2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Cardiac disorders
Sinus tachycardia_3
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Nervous system disorders
Somnolence_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Vascular disorders
Superficial thrombophlebitis_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Blood and lymphatic system disorders
Thrombocytopenia_1
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Injury, poisoning and procedural complications
Traumatic ulcer_3
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Infections and infestations
Upper respiratory tract infection_2
|
33.3%
1/3 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
|
Gastrointestinal disorders
Vomiting_2
|
0.00%
0/3 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
50.0%
1/2 • Number of events 1 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
0.00%
0/2 • from randomization through study completion, up to 57 months, an average of 45 months
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
|
Additional Information
Fondazione EMN Italy Onlus
Fondazione EMN Italy Onlus
Phone: +39 011 0243236
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place