Trial Outcomes & Findings for Alternating Ixazomib Citrate and Lenalidomide as Maintenance Therapy After Stem Cell Transplant in Treating Patients With Multiple Myeloma (NCT NCT02619682)
NCT ID: NCT02619682
Last Updated: 2026-01-08
Results Overview
Adverse events Toxicity during the 24 months plus one month of post autologous transplant maintenance therapy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
2 years plus one month
Results posted on
2026-01-08
Participant Flow
all patients enrolled on study were treated on study
Participant milestones
| Measure |
Post Auto Transplant Maintenance Therapy
only one arm of study : all patients treated on study with same maintenance therapy
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Post Auto Transplant Maintenance Therapy
only one arm of study : all patients treated on study with same maintenance therapy
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lack of Efficacy
|
8
|
|
Overall Study
new secondary cancer
|
1
|
|
Overall Study
post surgery complications
|
2
|
Baseline Characteristics
Alternating Ixazomib Citrate and Lenalidomide as Maintenance Therapy After Stem Cell Transplant in Treating Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Post Autologous Transplant Maintenance
n=30 Participants
one treatment arm all patients enrolled on study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=18 Participants
|
|
number of participants treated
|
30 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 2 years plus one monthAdverse events Toxicity during the 24 months plus one month of post autologous transplant maintenance therapy
Outcome measures
| Measure |
Post Autologous Transplant Maintenance
n=30 Participants
one arm = all enrolled MM patients got post autologous transplant maintenance therapy
|
|---|---|
|
Number of Participants With Adverse Events, Graded According to CTCAE Version 4.0
|
30 Participants
|
SECONDARY outcome
Timeframe: Median 4.6 years from start of therapyall MM patients who got post autologous transplant study therapy
Outcome measures
| Measure |
Post Autologous Transplant Maintenance
n=30 Participants
one arm = all enrolled MM patients got post autologous transplant maintenance therapy
|
|---|---|
|
Overall Survival
|
21 Participants
|
SECONDARY outcome
Timeframe: Median of 4.6 years from start of study therapyOutcome measures
| Measure |
Post Autologous Transplant Maintenance
n=30 Participants
one arm = all enrolled MM patients got post autologous transplant maintenance therapy
|
|---|---|
|
Disease Free Survival
|
11 Participants
|
Adverse Events
Post Autologous Transplant Maintenance
Serious events: 4 serious events
Other events: 30 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Post Autologous Transplant Maintenance
n=30 participants at risk
one arm = all enrolled MM patients got post autologous transplant maintenance therapy
|
|---|---|
|
Infections and infestations
pneumonia with sepsis
|
3.3%
1/30 • Number of events 1 • Median 4.6 years from start of therapy
|
|
Infections and infestations
Pneumonia without sepsis
|
3.3%
1/30 • Number of events 1 • Median 4.6 years from start of therapy
|
|
Infections and infestations
RSV Upper respiratory tract infection
|
3.3%
1/30 • Number of events 1 • Median 4.6 years from start of therapy
|
|
Cardiac disorders
palpitations
|
3.3%
1/30 • Number of events 1 • Median 4.6 years from start of therapy
|
Other adverse events
| Measure |
Post Autologous Transplant Maintenance
n=30 participants at risk
one arm = all enrolled MM patients got post autologous transplant maintenance therapy
|
|---|---|
|
Infections and infestations
urinary tract infection
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Investigations
ANC decreased
|
23.3%
7/30 • Median 4.6 years from start of therapy
|
|
General disorders
fatigue
|
6.7%
2/30 • Median 4.6 years from start of therapy
|
|
Infections and infestations
cellulitis
|
10.0%
3/30 • Median 4.6 years from start of therapy
|
|
Gastrointestinal disorders
vomiting
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Skin and subcutaneous tissue disorders
rash
|
6.7%
2/30 • Median 4.6 years from start of therapy
|
|
Blood and lymphatic system disorders
anemia
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Metabolism and nutrition disorders
hypokalemia
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Investigations
Creatinine increased
|
6.7%
2/30 • Median 4.6 years from start of therapy
|
|
Investigations
ALT increased
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Gastrointestinal disorders
diarrhea
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Metabolism and nutrition disorders
albumin decreased
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Psychiatric disorders
insomnia
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Vascular disorders
hypertension
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Infections and infestations
giardia gastrointestinal infection
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Vascular disorders
superficial vein blood clot
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Infections and infestations
bronchitis
|
6.7%
2/30 • Median 4.6 years from start of therapy
|
|
Infections and infestations
thrush oral
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Infections and infestations
Zoster
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Investigations
hyperglycemia
|
6.7%
2/30 • Median 4.6 years from start of therapy
|
|
Investigations
hypoglycemia
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
|
Investigations
lymphocyte decreased
|
33.3%
10/30 • Median 4.6 years from start of therapy
|
|
Metabolism and nutrition disorders
phosphorus decreased
|
16.7%
5/30 • Median 4.6 years from start of therapy
|
|
Infections and infestations
upper respiratory tract infection
|
13.3%
4/30 • Median 4.6 years from start of therapy
|
|
Investigations
WBC decreased
|
20.0%
6/30 • Median 4.6 years from start of therapy
|
|
Investigations
Platelet decreased
|
3.3%
1/30 • Median 4.6 years from start of therapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place