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Trial Outcomes & Findings for Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Myeloma (NCT NCT04119336)

NCT ID: NCT04119336

Last Updated: 2023-08-21

Results Overview

ORR is defined as percentage of participants with complete response (CR) and partial response (PR) per International Myeloma Working Group (IMWG) criteria below. * CR = Negative immunofixation on serum and urine; disappearance of soft tissue plasmacytomas, and \<5% plasma cells in bone marrow * Stringent CR = Above definition plus normal FLC ration and absence of clonal cells in bone marrow by IHC or 2-4 color flow cytometry * PR = At least 50% reduction of serum M-protein and reduction in 24 urinary M-protein by at least 90% or to \<200 mg/24 h. If serum and urine M-protein unmeasurable, require at least 50% decrease in difference between involved and uninvolved FLC levels. If serum free light assay also unmeasurable, require at least 50% reduction in plasma cells, provided baseline was at least 30% * Very Good PR (VGPR) = Serum and urine M-protein detectable by immunofixation but not on electrophoresis, or \>90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 h

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

up to 8 months

Results posted on

2023-08-21

Participant Flow

Participant milestones

Participant milestones
Measure
Nivolumab and Ixazomib
\- Participants will receive Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone on a 28-day cycle. * Oral: * Ixazomib given weekly on days 1, 8, 15 * Dexamethasone given weekly during cycle * Infused: * Nivolumab given once per cycle * Cyclophosphamide given on days 1, 8, 15 during cycle Nivolumab: Given intravenously once per cycle Ixazomib: Given orally on days 1, 8, 15. Dexamethasone: Given orally on days 1, 8, 15, 22 Cyclophosphamide: Given intravenously on days 1, 8, 15.
Overall Study
STARTED
2
Overall Study
COMPLETED
2
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Nivolumab and Ixazomib
n=2 Participants
\- Participants will receive Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone on a 28-day cycle. * Oral: * Ixazomib given weekly on days 1, 8, 15 * Dexamethasone given weekly during cycle * Infused: * Nivolumab given once per cycle * Cyclophosphamide given on days 1, 8, 15 during cycle Nivolumab: Given intravenously once per cycle Ixazomib: Given orally on days 1, 8, 15. Dexamethasone: Given orally on days 1, 8, 15, 22 Cyclophosphamide: Given intravenously on days 1, 8, 15.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
1 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
1 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants

PRIMARY outcome

Timeframe: up to 8 months

ORR is defined as percentage of participants with complete response (CR) and partial response (PR) per International Myeloma Working Group (IMWG) criteria below. * CR = Negative immunofixation on serum and urine; disappearance of soft tissue plasmacytomas, and \<5% plasma cells in bone marrow * Stringent CR = Above definition plus normal FLC ration and absence of clonal cells in bone marrow by IHC or 2-4 color flow cytometry * PR = At least 50% reduction of serum M-protein and reduction in 24 urinary M-protein by at least 90% or to \<200 mg/24 h. If serum and urine M-protein unmeasurable, require at least 50% decrease in difference between involved and uninvolved FLC levels. If serum free light assay also unmeasurable, require at least 50% reduction in plasma cells, provided baseline was at least 30% * Very Good PR (VGPR) = Serum and urine M-protein detectable by immunofixation but not on electrophoresis, or \>90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 h

Outcome measures

Outcome measures
Measure
Nivolumab and Ixazomib
n=2 Participants
\- Participants will receive Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone on a 28-day cycle. * Oral: * Ixazomib given weekly on days 1, 8, 15 * Dexamethasone given weekly during cycle * Infused: * Nivolumab given once per cycle * Cyclophosphamide given on days 1, 8, 15 during cycle Nivolumab: Given intravenously once per cycle Ixazomib: Given orally on days 1, 8, 15. Dexamethasone: Given orally on days 1, 8, 15, 22 Cyclophosphamide: Given intravenously on days 1, 8, 15.
Objective Response Rate (ORR)
0 percentage of participants

SECONDARY outcome

Timeframe: Up to 2 years

Progression-free survival (PFS) is defined as the time from starting study treatment to disease progression or death from any cause. The International Myeloma Working Group (IMWG) criteria defines progressive disease (PD) as at least 25% increase from lowest response value of any of the following: * Serum M-component (absolute increase must be at least 0.5 g/dL) * Urine M-component (absolute increase must be at least 200 mg/24 h) * If serum and urine M-protein unmeasurable, absolute increase in free light chain (FLC) must be \>10 mg/dL. If FLC levels also unmeasurable, absolute increase in bone marrow plasma cell percentage must be at least 10%. * Definite development of new bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder

Outcome measures

Outcome measures
Measure
Nivolumab and Ixazomib
n=2 Participants
\- Participants will receive Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone on a 28-day cycle. * Oral: * Ixazomib given weekly on days 1, 8, 15 * Dexamethasone given weekly during cycle * Infused: * Nivolumab given once per cycle * Cyclophosphamide given on days 1, 8, 15 during cycle Nivolumab: Given intravenously once per cycle Ixazomib: Given orally on days 1, 8, 15. Dexamethasone: Given orally on days 1, 8, 15, 22 Cyclophosphamide: Given intravenously on days 1, 8, 15.
Progression Free Survival
3.96 months
Interval 1.15 to
Upper limit was not reached due to insufficient number of participants with events.

Adverse Events

Nivolumab and Ixazomib

Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Nivolumab and Ixazomib
n=2 participants at risk
\- Participants will receive Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone on a 28-day cycle. * Oral: * Ixazomib given weekly on days 1, 8, 15 * Dexamethasone given weekly during cycle * Infused: * Nivolumab given once per cycle * Cyclophosphamide given on days 1, 8, 15 during cycle Nivolumab: Given intravenously once per cycle Ixazomib: Given orally on days 1, 8, 15. Dexamethasone: Given orally on days 1, 8, 15, 22 Cyclophosphamide: Given intravenously on days 1, 8, 15.
Gastrointestinal disorders
Constipation
50.0%
1/2 • up to 2 years
Gastrointestinal disorders
Gastroesophageal reflux disease
50.0%
1/2 • up to 2 years
General disorders
Fatigue
50.0%
1/2 • up to 2 years
General disorders
Pain
50.0%
1/2 • up to 2 years
Investigations
Aspartate aminotransferase increased
50.0%
1/2 • up to 2 years
Investigations
Alkaline phosphatase increased
50.0%
1/2 • up to 2 years
Investigations
White blood cell decreased
50.0%
1/2 • up to 2 years
Investigations
Neutrophil count decreased
50.0%
1/2 • up to 2 years
Investigations
Platelet count decreased
50.0%
1/2 • up to 2 years
Musculoskeletal and connective tissue disorders
Back Pain
50.0%
1/2 • up to 2 years
Psychiatric disorders
Anxiety
50.0%
1/2 • up to 2 years
Psychiatric disorders
Depression
50.0%
1/2 • up to 2 years
Psychiatric disorders
Personality change (mood changes)
50.0%
1/2 • up to 2 years
Vascular disorders
Hypertension
50.0%
1/2 • up to 2 years

Additional Information

Andrew Yee, MD

Massachusetts General Hospital

Phone: 617-724-4000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place