Trial Outcomes & Findings for Isa-Pom-Dex in Elderly/Frail Subjects With RRMM (NCT NCT05911321)

Last Updated: 2026-05-20

Results Overview

Overall response rate (ORR) is defined as the proportion of participants achieving a partial response or better (≥PR) per IMWG criteria. The number of participants achieved at least partial response reported. Complete response (CR) requires negative serum and urine immunofixation, disappearance of plasmacytomas, and \<5% bone marrow plasma cells; stringent complete response (sCR) requires CR plus a normal free light chain ratio and no clonal plasma cells in bone marrow. Very good partial response (VGPR) is defined as M-protein detectable by immunofixation but not electrophoresis, or a ≥90% reduction in serum M-protein with urine M-protein \<100 mg/24h. Partial response (PR) is defined as a ≥50% reduction in serum M-protein and a ≥90% reduction in 24-hour urine M-protein (or to \<200 mg/24h), with a ≥50% reduction in plasmacytomas if present at baseline.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Up to 12 weeks

Results posted on

2026-05-20

Participant Flow

Six participants were enrolled at a single U.S. center between December 5, 2023, and March 20, 2025.

Participant milestones

Participant milestones
Measure	Experimental: Single Arm Subjects with relapsed or refractory multiple myeloma receiving the study treatment.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Single Arm Subjects with relapsed or refractory multiple myeloma receiving the study treatment.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Isa-Pom-Dex in Elderly/Frail Subjects With RRMM

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Single Arm n=6 Participants Subjects with relapsed or refractory multiple myeloma receiving the study treatment.
Age, Continuous	72 years n=30 Participants
Sex: Female, Male Female	3 Participants n=30 Participants
Sex: Female, Male Male	3 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	3 Participants n=30 Participants
Race (NIH/OMB) White	2 Participants n=30 Participants
Race (NIH/OMB) More than one race	1 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants
Region of Enrollment United States	6 participants n=30 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Participants received study treatment for up to 12 weeks, at which point tumor response was assessed.

Outcome measures

Outcome measures
Measure	Experimental: Single Arm n=5 Participants Subjects with relapsed or refractory multiple myeloma receiving the study treatment.
Overall Response Rate (ORR)	4 Participants

SECONDARY outcome

Timeframe: Up to 12 weeks

All treatment-related adverse events as defined by changes from baseline utilizing National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0. NCI-CTCAE is a descriptive terminology utilized for AE reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

TFFS is defined as the time start from the first day of study therapy until discontinuation for any reason, including disease progression, toxicity, or death. Progressive disease: Serum M-protein: absolute increase must be ≥ 0.5 g/dL, ≥ 1 g/dL if the lowest M component was ≥ 5 g/dL; absolute Urine M-protein increase≥ 200 mg/24 h). In patients without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be \> 10 mg/dL; without measurable involved FLC levels, bone marrow plasma cell percentage irrespective of baseline status Appearance of a new lesion(s), ≥ 50% increase from nadir \> 1 lesion, or ≥ 50% increase in the longest diameter of a previous lesion \>1 cm in short axis;≥ 50% increase e in circulating plasma cells (minimum of 200 cells per μL) if this is the only measure of disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Maximum depth of response includes the summation of minimal response (MR), partial response (PR), very good partial response (VGPR), complete response (CR), and stringent complete response (sCR) based on IMWG criteria. Minimal response(MR): ≥ 25% but ≤ 49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%, if present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. PR, VGPR, CR, and sCR were defined above.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

CBR is defined as a partial response or better (≥PR) + minimal response (MR) rate based on International Myeloma Working Group (IMWG) criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Bone marrow minimal residual disease (MRD) negativity will be defined as the ratio of subjects who achieved MRD to all subjects. MRD negativity will be assessed by next-generation sequencing with a minimum sensitivity of 1x10-5.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Time to first response is defined as the time from the first study treatment to the achievement of PR or better as defined by IMWG criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Time to best response is defined as the time from the first study treatment to the achievement of best response (PR, VGPR, CR, or sCR) based on IMWG criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Duration of response is defined as the time from the achievement of PR or better until progressive disease (PD) based on IMWG criteria. Subjects will be censored if they die of anything other than myeloma.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

PFS is defined as the time from the first study treatment until confirmed PD based on IMWG criteria or death from any cause, whichever comes first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Median time to next treatment (TTNT) is defined as the time from the start of the study treatment to the next type of Multiple Myeloma treatment or death from any cause, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Overall survival is defined as the time from the first study treatment to death from any cause.

Outcome measures

Outcome data not reported

Adverse Events

Experimental: Single Arm

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental: Single Arm n=6 participants at risk Subjects with relapsed or refractory multiple myeloma receiving the study treatment.
Blood and lymphatic system disorders Anemia	33.3% 2/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Eye disorders Watering eyes	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Gastrointestinal disorders Bloating	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Gastrointestinal disorders Constipation	66.7% 4/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Gastrointestinal disorders Diarrhea	33.3% 2/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Gastrointestinal disorders Dry mouth	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
General disorders Edema limbs	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
General disorders Fatigue	33.3% 2/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
General disorders Flu like symptoms	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
General disorders Non-cardiac chest pain	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Immune system disorders Allergic reaction	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Infections and infestations Infections and infestations - Other, specify	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Infections and infestations Upper respiratory infection	50.0% 3/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Injury, poisoning and procedural complications Infusion related reaction	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Investigations Aspartate aminotransferase increased	33.3% 2/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Investigations Lymphocyte count decreased	83.3% 5/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Investigations Neutrophil count decreased	100.0% 6/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Investigations Platelet count decreased	33.3% 2/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Investigations White blood cell decreased	66.7% 4/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Metabolism and nutrition disorders Hyperglycemia	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Metabolism and nutrition disorders Hypernatremia	50.0% 3/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Investigations Hypoalbuminemia	50.0% 3/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Investigations Hypocalcemia	33.3% 2/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Investigations Hypokalemia	33.3% 2/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Investigations Hypophosphatemia	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Musculoskeletal and connective tissue disorders Muscle cramp	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Nervous system disorders Amnesia	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Nervous system disorders Dizziness	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Nervous system disorders Dysgeusia	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Nervous system disorders Headache	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Nervous system disorders Tremor	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Psychiatric disorders Anxiety	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Psychiatric disorders Insomnia	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Renal and urinary disorders Urinary urgency	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0
Skin and subcutaneous tissue disorders "Skin and subcutaneous tissue disorders - Other, specify"	16.7% 1/6 • Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up. CTCAE version 5.0

Additional Information

Melahat Canter

UNC Lineberger Comprehensive Cancer Center

Phone: (919) 962-0000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place