Trial Outcomes & Findings for Lenalidomide and Dexamethasone With or Without Anakinra in Treating Patients With Early Stage Multiple Myeloma (NCT NCT02492750)
NCT ID: NCT02492750
Last Updated: 2020-03-25
Results Overview
Number of participants experiencing a dose-limiting toxicity (DLT) is reported below. Dose-limiting toxicity is graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
28 days
Results posted on
2020-03-25
Participant Flow
Participant milestones
| Measure |
Phase I - Dose Level 1
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 2
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 3
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
6
|
|
Overall Study
COMPLETED
|
4
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data available are summarized here (i.e. participants with missing data are not included in this analysis).
Baseline characteristics by cohort
| Measure |
Phase I - Dose Level 1
n=4 Participants
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 2
n=4 Participants
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 3
n=6 Participants
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 years
n=4 Participants
|
62.5 years
n=4 Participants
|
58.5 years
n=6 Participants
|
60 years
n=14 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=6 Participants
|
14 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
|
ISS Stage of myeloma at diagnosis
I
|
1 Participants
n=2 Participants • Data available are summarized here (i.e. participants with missing data are not included in this analysis).
|
0 Participants
n=1 Participants • Data available are summarized here (i.e. participants with missing data are not included in this analysis).
|
5 Participants
n=6 Participants • Data available are summarized here (i.e. participants with missing data are not included in this analysis).
|
6 Participants
n=9 Participants • Data available are summarized here (i.e. participants with missing data are not included in this analysis).
|
|
ISS Stage of myeloma at diagnosis
II
|
1 Participants
n=2 Participants • Data available are summarized here (i.e. participants with missing data are not included in this analysis).
|
1 Participants
n=1 Participants • Data available are summarized here (i.e. participants with missing data are not included in this analysis).
|
1 Participants
n=6 Participants • Data available are summarized here (i.e. participants with missing data are not included in this analysis).
|
3 Participants
n=9 Participants • Data available are summarized here (i.e. participants with missing data are not included in this analysis).
|
|
ECOG Performance Score at baseline
0
|
3 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=6 Participants
|
11 Participants
n=14 Participants
|
|
ECOG Performance Score at baseline
1
|
1 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: 28 daysNumber of participants experiencing a dose-limiting toxicity (DLT) is reported below. Dose-limiting toxicity is graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Phase I - Dose Level 1
n=4 Participants
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 2
n=4 Participants
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 3
n=6 Participants
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
|---|---|---|---|
|
Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 41 monthsThe number of participants who experienced at least one grade 3+ adverse events deemed at least possibly related to treatment, graded according to NCI CTCAE version 4.0, is reported below.
Outcome measures
| Measure |
Phase I - Dose Level 1
n=4 Participants
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 2
n=4 Participants
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 3
n=6 Participants
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
|---|---|---|---|
|
Number of Participants Who Experienced at Least One Grade 3+ Adverse Events Deemed at Least Possibly Related to Treatment, Graded According to NCI CTCAE Version 4.0
|
2 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 41 monthsThe following response terms will be used: stringent Complete Response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), Minimal Response (MR), stable disease (SD), and progressive disease (PD). The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy. PR defined as: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24hrs; ≥ 50% reduction in the size of soft tissue plasmacytomas. MR defined as: ≥25% but ≤ 49% reduction of serum M protein and reduction in 24-hour urine M-protein by 50-89% which still exceeds 200mg/24 hours; 25-49% reduction in the size of soft tissue plasmacytoma and No increase in the size or number of lytic bone lesions. VGPR defined as: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein \<100 mg/24 h
Outcome measures
| Measure |
Phase I - Dose Level 1
n=4 Participants
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 2
n=4 Participants
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 3
n=6 Participants
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
|---|---|---|---|
|
Best Response
Partial Response (PR)
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Best Response
Minimal Response (MR)
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Best Response
Very Good Partial Response (VGPR)
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Phase I - Dose Level 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase I - Dose Level 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase I - Dose Level 3
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase I - Dose Level 1
n=4 participants at risk
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 2
n=4 participants at risk
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 3
n=6 participants at risk
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
|---|---|---|---|
|
Infections and infestations
Lung infection
|
25.0%
1/4 • Number of events 1 • Up to 41 months
|
0.00%
0/4 • Up to 41 months
|
0.00%
0/6 • Up to 41 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • Up to 41 months
|
25.0%
1/4 • Number of events 1 • Up to 41 months
|
0.00%
0/6 • Up to 41 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Up to 41 months
|
25.0%
1/4 • Number of events 1 • Up to 41 months
|
0.00%
0/6 • Up to 41 months
|
|
Vascular disorders
Thromboembolic event
|
25.0%
1/4 • Number of events 1 • Up to 41 months
|
0.00%
0/4 • Up to 41 months
|
16.7%
1/6 • Number of events 1 • Up to 41 months
|
Other adverse events
| Measure |
Phase I - Dose Level 1
n=4 participants at risk
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 2
n=4 participants at risk
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
Phase I - Dose Level 3
n=6 participants at risk
Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
4/4 • Number of events 60 • Up to 41 months
|
75.0%
3/4 • Number of events 8 • Up to 41 months
|
50.0%
3/6 • Number of events 19 • Up to 41 months
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 23 • Up to 41 months
|
100.0%
4/4 • Number of events 24 • Up to 41 months
|
83.3%
5/6 • Number of events 11 • Up to 41 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 35 • Up to 41 months
|
75.0%
3/4 • Number of events 12 • Up to 41 months
|
83.3%
5/6 • Number of events 20 • Up to 41 months
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • Number of events 2 • Up to 41 months
|
0.00%
0/4 • Up to 41 months
|
0.00%
0/6 • Up to 41 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 26 • Up to 41 months
|
25.0%
1/4 • Number of events 1 • Up to 41 months
|
33.3%
2/6 • Number of events 2 • Up to 41 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to 41 months
|
25.0%
1/4 • Number of events 1 • Up to 41 months
|
16.7%
1/6 • Number of events 1 • Up to 41 months
|
|
General disorders
Fatigue
|
100.0%
4/4 • Number of events 71 • Up to 41 months
|
75.0%
3/4 • Number of events 13 • Up to 41 months
|
50.0%
3/6 • Number of events 18 • Up to 41 months
|
|
General disorders
Injection site reaction
|
100.0%
4/4 • Number of events 8 • Up to 41 months
|
100.0%
4/4 • Number of events 12 • Up to 41 months
|
83.3%
5/6 • Number of events 15 • Up to 41 months
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/4 • Up to 41 months
|
25.0%
1/4 • Number of events 1 • Up to 41 months
|
0.00%
0/6 • Up to 41 months
|
|
Investigations
Creatinine increased
|
25.0%
1/4 • Number of events 1 • Up to 41 months
|
0.00%
0/4 • Up to 41 months
|
33.3%
2/6 • Number of events 2 • Up to 41 months
|
|
Investigations
Lymphocyte count decreased
|
75.0%
3/4 • Number of events 10 • Up to 41 months
|
75.0%
3/4 • Number of events 13 • Up to 41 months
|
33.3%
2/6 • Number of events 9 • Up to 41 months
|
|
Investigations
Neutrophil count decreased
|
75.0%
3/4 • Number of events 32 • Up to 41 months
|
75.0%
3/4 • Number of events 27 • Up to 41 months
|
83.3%
5/6 • Number of events 24 • Up to 41 months
|
|
Investigations
Platelet count decreased
|
75.0%
3/4 • Number of events 41 • Up to 41 months
|
50.0%
2/4 • Number of events 7 • Up to 41 months
|
0.00%
0/6 • Up to 41 months
|
|
Investigations
White blood cell decreased
|
75.0%
3/4 • Number of events 13 • Up to 41 months
|
50.0%
2/4 • Number of events 11 • Up to 41 months
|
33.3%
2/6 • Number of events 16 • Up to 41 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 3 • Up to 41 months
|
0.00%
0/4 • Up to 41 months
|
0.00%
0/6 • Up to 41 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • Up to 41 months
|
0.00%
0/4 • Up to 41 months
|
0.00%
0/6 • Up to 41 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Up to 41 months
|
0.00%
0/4 • Up to 41 months
|
16.7%
1/6 • Number of events 3 • Up to 41 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
1/4 • Number of events 5 • Up to 41 months
|
50.0%
2/4 • Number of events 29 • Up to 41 months
|
66.7%
4/6 • Number of events 20 • Up to 41 months
|
|
Psychiatric disorders
Agitation
|
25.0%
1/4 • Number of events 1 • Up to 41 months
|
0.00%
0/4 • Up to 41 months
|
16.7%
1/6 • Number of events 1 • Up to 41 months
|
|
Psychiatric disorders
Delusions
|
0.00%
0/4 • Up to 41 months
|
25.0%
1/4 • Number of events 1 • Up to 41 months
|
0.00%
0/6 • Up to 41 months
|
|
Psychiatric disorders
Euphoria
|
0.00%
0/4 • Up to 41 months
|
25.0%
1/4 • Number of events 1 • Up to 41 months
|
0.00%
0/6 • Up to 41 months
|
|
Psychiatric disorders
Insomnia
|
100.0%
4/4 • Number of events 55 • Up to 41 months
|
100.0%
4/4 • Number of events 39 • Up to 41 months
|
83.3%
5/6 • Number of events 28 • Up to 41 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
50.0%
2/4 • Number of events 4 • Up to 41 months
|
0.00%
0/4 • Up to 41 months
|
16.7%
1/6 • Number of events 1 • Up to 41 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
75.0%
3/4 • Number of events 6 • Up to 41 months
|
75.0%
3/4 • Number of events 7 • Up to 41 months
|
0.00%
0/6 • Up to 41 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • Up to 41 months
|
25.0%
1/4 • Number of events 1 • Up to 41 months
|
0.00%
0/6 • Up to 41 months
|
|
Vascular disorders
Thromboembolic event
|
25.0%
1/4 • Number of events 7 • Up to 41 months
|
0.00%
0/4 • Up to 41 months
|
0.00%
0/6 • Up to 41 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place