Trial Outcomes & Findings for Abatacept, Ixazomib Citrate, and Dexamethasone in Treating Patients With Multiple Myeloma Resistant to Chemotherapy (NCT NCT03457142)

Last Updated: 2025-03-04

Results Overview

Will be compared to historical controls of ixazomib citrate + dexamethasone. Responses to treatment will be measured by serum immunoglobulins, serum free kappa and lambda light chains, serum protein electrophoresis/immunofixation electrophoresis, and 24-hour urine protein electrophoresis/immunofixation. International uniform response criteria will be used. The anti-myeloma activity will be evaluated on an exploratory basis and will be summarized using descriptive statistics or graphical methods. No formal comparison will be carried forth.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

1 cycle of 28 days

Results posted on

2025-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abatacept: Given IV and SC Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abatacept: Given IV and SC Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies
Overall Study Death	1

Baseline Characteristics

Abatacept, Ixazomib Citrate, and Dexamethasone in Treating Patients With Multiple Myeloma Resistant to Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) n=15 Participants Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abatacept: Given IV and SC Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies
Age, Continuous	64.2 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 cycle of 28 days

Population: 1 patient experienced death prior to disease response assessment.

Outcome measures

Outcome measures
Measure	Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) n=14 Participants Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abatacept: Given IV and SC Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies
Response Rate of Abatacept + Ixazomib Citrate + Dexamethasone in Multiple Myeloma Patients Complete Response	1 Participants
Response Rate of Abatacept + Ixazomib Citrate + Dexamethasone in Multiple Myeloma Patients Partial Response	4 Participants
Response Rate of Abatacept + Ixazomib Citrate + Dexamethasone in Multiple Myeloma Patients Stable Disease	8 Participants
Response Rate of Abatacept + Ixazomib Citrate + Dexamethasone in Multiple Myeloma Patients Progressive Disease	1 Participants

SECONDARY outcome

Timeframe: Up to 30 days after last dose

The adverse events and drug related toxicities will be summarized by grade using frequencies and relative frequencies. The rate of grade 3 or higher toxicities that are probably or definitely related to abatacept will be reported with 90% confidence intervals obtained using Jeffrey?s prior method.

Outcome measures

Outcome measures
Measure	Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) n=15 Participants Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abatacept: Given IV and SC Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies
Incidence of Adverse Events Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0	5 Participants

SECONDARY outcome

Timeframe: From the date of the first study treatment until initiation of a new therapy, death, or end of follow-up (up to 5 years); whichever occurs first.

Defined as the time from treatment initiation until death or last follow-up. Will be summarized using standard Kaplan-Meier methods; where estimates of median survival and survival rates will be obtained with 90% confidence intervals.

Outcome measures

Outcome measures
Measure	Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) n=15 Participants Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abatacept: Given IV and SC Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies
Overall Survival	33.6 months Interval 14.5 to Insufficient number of events observed to calculate the upper bound for the 90% confidence interval.

SECONDARY outcome

Timeframe: From the date of the first study treatment to the date of first observed disease progression or death due to any cause, assessed up to 5 years

Defined as the time from treatment initiation until disease progression, death, or last follow-up. Will be summarized using standard Kaplan-Meier methods; where estimates of median survival and survival rates will be obtained with 90% confidence intervals.

Outcome measures

Outcome measures
Measure	Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) n=15 Participants Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abatacept: Given IV and SC Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies
Progression-free Survival	11.1 months Interval 5.7 to 15.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Population: These measurements were not collected and are not available for reporting.

The expression/levels and response will be evaluated using logistic regression models.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Population: These measurements were not collected and are not available for reporting.

The association between CD28, CD86, serum kynurenine and IL-6 expression/levels and response will be evaluated using logistic regression models.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Abatacept, Ixazomib Citrate, Dexamethasone)

Serious events: 1 serious events

Other events: 14 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) n=15 participants at risk Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abatacept: Given IV and SC Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies
Gastrointestinal disorders Diarrhea	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Investigations Platelet count decreased	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.

Other adverse events

Other adverse events
Measure	Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) n=15 participants at risk Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abatacept: Given IV and SC Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies
Cardiac disorders Sinus tachycardia	13.3% 2/15 • Number of events 2 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Ear and labyrinth disorders Vertigo	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Eye disorders Blurred vision	13.3% 2/15 • Number of events 2 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Gastrointestinal disorders Constipation	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Gastrointestinal disorders Diarrhea	53.3% 8/15 • Number of events 8 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Gastrointestinal disorders Dyspepsia	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Gastrointestinal disorders Gastroesophageal reflux disease	13.3% 2/15 • Number of events 2 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Gastrointestinal disorders Stomach pain	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Gastrointestinal disorders Oral dysesthesia	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
General disorders Edema limbs	13.3% 2/15 • Number of events 2 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
General disorders Fatigue	40.0% 6/15 • Number of events 6 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
General disorders Generalized edema	13.3% 2/15 • Number of events 2 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
General disorders Injection site reaction	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Infections and infestations Joint infection	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Infections and infestations Upper respiratory infection	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Injury, poisoning and procedural complications Bruising	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Investigations Platelet count decreased	20.0% 3/15 • Number of events 3 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Investigations Weight gain	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Metabolism and nutrition disorders Hypocalcemia	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Musculoskeletal and connective tissue disorders Myalgia	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Nervous system disorders Dizziness	13.3% 2/15 • Number of events 2 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Nervous system disorders Headache	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Nervous system disorders Peripheral motor neuropathy	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Nervous system disorders Peripheral sensory neuropathy	13.3% 2/15 • Number of events 2 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Nervous system disorders Tremor	13.3% 2/15 • Number of events 2 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Psychiatric disorders Agitation	13.3% 2/15 • Number of events 2 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Psychiatric disorders Anxiety	13.3% 2/15 • Number of events 2 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Psychiatric disorders Depression	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Psychiatric disorders Insomnia	40.0% 6/15 • Number of events 6 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Respiratory, thoracic and mediastinal disorders Hoarseness	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.7% 1/15 • Number of events 1 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Vascular disorders Flushing	13.3% 2/15 • Number of events 2 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Vascular disorders Hot flashes	13.3% 2/15 • Number of events 2 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.
Vascular disorders Hypertension	13.3% 2/15 • Number of events 2 • Adverse events were captured from the start of treatment until up to 30 days after the end of treatment; which ranged from 1.4 to 16.6 months (median = 6.8 months). All-cause mortality is captured for up to 5 years post treatment initiation.

Additional Information

Kris Attwood

Roswell Park Comprehensive Cancer Center

Phone: 716-845-2300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place