A Phase 2 interventional study of Abatacept and Dexamethasone in Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma, sponsored by Roswell Park Cancer Institute. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Roswell Park Cancer Institute · Phase 2, Interventional, and Treatment
This phase II trial studies how well abatacept, ixazomib citrate, and dexamethasone work in treating patients with multiple myeloma that is resistant to chemotherapy. Abatacept may block certain proteins that are present on multiple myeloma cells that have been shown to protect against chemotherapy. Drugs used in chemotherapy, such as ixazomib citrate and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving abatacept, ixazomib citrate, and dexamethasone may work better at treating patients with multiple myeloma resistant to chemotherapy.
PRIMARY OBJECTIVES:
I. To determine the therapeutic efficacy (as measured by response rate) of abatacept + ixazomib citrate (ixazomib) + dexamethasone in multiple myeloma patients who have relapsed (or who are primary refractory) following treatment with their first proteasome inhibitor-containing regimen (excluding ixazomib), compared to historical controls of ixazomib + dexamethasone.
SECONDARY OBJECTIVES:
I. To assess the toxicity profile of abatacept + ixazomib + dexamethasone in multiple myeloma patients who have relapsed (or who are primary refractory) following treatment with their first proteasome inhibitor-containing regimen, compared to historical controls of ixazomib + dexamethasone.
II. To assess progression-free and overall survival profile of abatacept + ixazomib + dexamethasone in multiple myeloma patients who have relapsed (or who are primary refractory) following treatment with their proteasome inhibitor-containing regimen, compared to historical controls of ixazomib + dexamethasone.
TERTIARY OBJECTIVES:
I. Assess whether myeloma expression of CD28, CD86, serum kynurenine and/or IL-6 are correlated with specific clinical outcomes.
OUTLINE:
Patients receive abatacept intravenously (IV) over 30 minutes on day 1 of course 1, then subcutaneously (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 orally (PO) once daily (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.
After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
Must be free of systemic infection:
Exclusion Criteria:
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.
Biological: Abatacept · Drug: Dexamethasone · Drug: Ixazomib Citrate · Other: Laboratory Biomarker Analysis
Given IV and SC
Also known as: BMS-188667, CTL A4-Ig B7 Inhibitor, CTLA4-Ig, cytotoxic T lymphocyte-associated antigen-4, Orencia, RG2077
Given PO
Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, Visumetazone
Given PO
Also known as: MLN-9708, MLN9708, Ninlaro
Correlative studies
Response Rate of Abatacept + Ixazomib Citrate + Dexamethasone in Multiple Myeloma Patients
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.
Time frame: 1 cycle of 28 days
Incidence of Adverse Events Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
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.
Time frame: Up to 30 days after last dose
Overall Survival
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.
Time frame: 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.
Progression-free Survival
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.
Time frame: 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
CD28 and CD86 Expression Assessed by Flow Cytometry
The expression/levels and response will be evaluated using logistic regression models.
Time frame: Up to 5 years
Serum Kynurenine and IL-6 Levels
The association between CD28, CD86, serum kynurenine and IL-6 expression/levels and response will be evaluated using logistic regression models.
Time frame: Up to 5 years
| Milestone | Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) |
|---|---|
| Started | 15 |
| Completed | 14 |
| Not completed | 1 |
| Withdrew: Death | 1 |
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.
| Participants | Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) |
|---|---|
| Complete Response | 1 |
| Partial Response | 4 |
| Stable Disease | 8 |
| Progressive Disease | 1 |
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.
| Participants | Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) |
|---|---|
| Incidence of Adverse Events Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | 5 |
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.
| months | Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) |
|---|---|
| Overall Survival | 33.6 (14.5 to NA) |
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.
| months | Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) |
|---|---|
| Progression-free Survival | 11.1 (5.7 to 15.9) |
The expression/levels and response will be evaluated using logistic regression models.
No measurements were reported for this outcome.
The association between CD28, CD86, serum kynurenine and IL-6 expression/levels and response will be evaluated using logistic regression models.
No measurements were reported for this outcome.
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) | 1/15 (6.7%) | 1/15 (6.7%) | 14/15 (93.3%) |
| Event | Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) |
|---|---|
| DiarrheaGastrointestinal disorders | 1/15 |
| Platelet count decreasedInvestigations | 1/15 |
| Event | Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) |
|---|---|
| DiarrheaGastrointestinal disorders | 8/15 |
| FatigueGeneral disorders | 6/15 |
| InsomniaPsychiatric disorders | 6/15 |
| Platelet count decreasedInvestigations | 3/15 |
| Sinus tachycardiaCardiac disorders | 2/15 |
| Blurred visionEye disorders | 2/15 |
| Gastroesophageal reflux diseaseGastrointestinal disorders | 2/15 |
| Edema limbsGeneral disorders | 2/15 |
| Generalized edemaGeneral disorders | 2/15 |
| DizzinessNervous system disorders | 2/15 |
| Age, Continuous(years) | Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) |
|---|---|
| Mean | 64.2 ± 10.2 |
| Sex: Female, Male(Participants) | Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) |
|---|---|
| Female | 5 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 15 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) |
|---|---|
| United States | 15 |
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Roswell Park Cancer Institute