Multiple MyelomaPhase 2NCT05911321
Isa-Pom-Dex in Elderly/Frail Subjects With RRMM
A Phase 2 study testing Isatuximab, Pomalidomide and Dexamethasone in people with Multiple Myeloma and Relapse, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This research study aims to evaluate the safety and effectiveness of the combination of isatuximab, pomalidomide, and dexamethasone (Isa-Pd) for the treatment of relapsed or refractory multiple myeloma (RRMM), which refers to multiple myeloma that has returned or has not responded to prior treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Relapse, Refractory
- What is being tested?
- Isatuximab, Pomalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Dec 2023to 26 Mar 2028
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information (PHI). Consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Age ≥ 18 years at the time of consent.
- Documented symptomatic multiple myeloma that has previously responded to therapy (partial response or better) and is relapsed or relapsed and refractory to the last line of therapy.
- Patients must also be refractory to at least one prior line of therapy that includes an IMiD and/or a PI, and should have received at least 2 cycles of that regimen to be evaluable for refractoriness .
- If previously treated with an anti-CD38 containing regimen, the subject must have achieved at least a PR to that line of therapy and must not have received an anti- CD38 mAb for at least 6 months prior to enrollment.
- Willing and able to adhere to the study visit schedule and other protocol requirements based on the judgement of the investigator.
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- Predicted high risk for severe toxicity from intensive regimens for RRMM, such as standard (full-dose) DPD, DVD, KPD, KRD, Ixa-PD, or Elo-PD as each regimen was published (such regimens often use, for example, twice-weekly bortezomib at 1.3 mg/m2, lenalidomide at 25 mg, or pomalidomide 4 mg). High-risk is defined as one of the following:
- Score ≥ 2 (indicating "frail") on the International Myeloma Working Group instrument (IMWG; Palumbo et al. [Blood 2015]) B.KPS ≤ 70
- Not meeting criteria A or B above but felt by treating clinician to not be a candidate for a standard full-dose regimen on account of one of the following:
- History of clinically significant non-hematologic grade ≥3 (NCI CTCAE, version 5.0) toxicity attributed to prior anticancer therapy ii) History of requiring dose-reduction of at least two separate anticancer drugs during prior therapy for multiple myeloma.
Who cannot join
- All subjects meeting any of the listed exclusion criteria at baseline with be excluded from study participation.
- Anti-myeloma treatment within 2 weeks of cycle 1 day 1
- Prior treatment with pomalidomide
- Any monoclonal antibody therapy within the previous 30-days
- Anti-CD38 monoclonal antibody therapy within the previous 6 months
- Autologous stem cell transplantation within 12 weeks of day 1 of cycle 1
- Subjects felt to not be candidates by treating physician for any systemic therapy due to excessive comorbidities, frailty, impaired performance status, or other severe limitations. Such limitations can be conceptualized generally as making subjects exceedingly high risk for any systemic treatment. These limitations often stem from medical comorbidities unrelated to MM and they are hence unlikely to improve with MM therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Study of Isatuximab Plus Pomalidomide and Dexamethasone in Highly Toxicity-vulnerable Subjects With Relapsed or Refractory Multiple Myeloma
This research study aims to evaluate the safety and effectiveness of the combination of isatuximab, pomalidomide, and dexamethasone (Isa-Pd) for the treatment of relapsed or refractory multiple myeloma (RRMM), which refers to multiple myeloma that has returned or has not responded to prior treatment. The study will specifically investigate the impact of administering lower-than-standard doses of pomalidomide and dexamethasone. Using lower doses of pomalidomide and dexamethasone in this setting has not been approved by the Food and Drug Administration (FDA).
Read the detailed description
This study aims to address the challenges faced in selecting appropriate therapy for elderly or highly toxicity-vulnerable patients who are poor candidates for standard (full-dose) chemotherapy regimens. Traditional clinical trials often exclude these patients, limiting the generalizability of available data. This single-arm multicenter phase II study will enroll 49 older and/or toxicity-vulnerable patients with RRMM. The study will evaluate the safety and effectiveness of isatuximab when used in combination with pomalidomide and dexamethasone at lower than standard doses. The primary objective is to estimate the overall response rate (ORR), while secondary objectives include the estimation of additional measures of response, as well as measures of toxicity and tolerability. All participants in the trial will also be evaluated by Cancer and Aging Research Group Geriatric Assessments (CARG-GA) and patient- reported outcome (PRO) measures of quality of life (QOL). Biomarkers of aging and frailty will also be studied.
Duration of therapy:
The duration of study participation will depend on the response to the treatment. In the absence of treatment delays due to adverse events, treatment with Isa-Pd will generally continue until disease progression, unacceptable side effects, other illness or condition that prevents further study treatment, or a subject's decision to withdraw from the study. On average, subjects will most likely be treated for approximately 10 months on this study.
Duration of Follow-Up:
All participants, including those withdrawn for adverse events (AEs) will be followed after removal from study treatment until death or full subject withdrawal from the study for other reasons. Participants removed from the study treatment for unacceptable AEs will be followed for resolution or stabilization of the AEs.
- Conditions
- Multiple Myeloma, Relapse, Refractory, Aging, Co-morbidity
- Being tested
- Isatuximab, Pomalidomide, Dexamethasone
- Keywords
- Pomalidomide, Isatuximab, Dexamethasone, low dose
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsatuximabDrug
Pharmaceutical form: Solution for infusion. Route of administration: Intravenous 10 mg/kg will be administered intravenously once weekly during cycle 1 and every other week during each subsequent cycle.
PomalidomideDrug
Pharmaceutical form: Pill for oral use. Route of administration: 3 mg Pomalidomide 3 mg pill will be taken by mouth once daily on days 1-21 of each 28-day cycle.
DexamethasoneDrug
Pharmaceutical form: Tablet for oral use Route of administration: Pill for oral use. Dexamethasone 20 mg tablet will be taken by mouth once per week.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Subjects with relapsed or refractory multiple myeloma receiving the study treatment. Receives: Drug: Isatuximab; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Overall response rate (ORR) is defined as the percentage of participants achieving a partial response or better (≥PR) per IMWG criteria. The number and percentage of participants achieving at least a partial response were 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.
Measured: Up to 12 weeks
Secondary outcomes (11)
Treatment Related Adverse Events Rate
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.
Measured: Up to 12 weeks
Treatment Failure-free Survival (TFFS)
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.
Measured: Up to 3 years
Maximum Depth of Response
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.
Measured: Up to 12 weeks
Clinical Benefit Rate (CBR)
CBR is defined as a partial response or better (≥PR) + minimal response (MR) rate based on International Myeloma Working Group (IMWG) criteria.
Measured: Up to 12 weeks
Bone Marrow Minimal Residual Disease (MRD) Negativity
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.
Measured: Up to 12 weeks
Time to First Response
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.
Measured: Up to 12 weeks
Time to Best Response
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.
Measured: Up to 12 weeks
Duration of Response
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.
Measured: Up to 3 years
Progression-free Survival (PFS)
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.
Measured: Up to 3 years
Median Time to Next Treatment (TTNT)
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.
Measured: Up to 3 years
Overall Survival
Overall survival is defined as the time from the first study treatment to death from any cause.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start5 Dec 2023
- Primary completion18 Jun 2025
- Study completion26 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Eben I Lichtman, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911321
- Sponsor's protocol ID
- LCCC2119
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2023
- Last updated
- 9 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Isatuximab Plus Pomalidomide and Dexamethasone in Highly Toxicity-vulnerable Subjects With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05911321
- Acronym / sponsor ID
- LCCC2119
- Conditions
- Multiple Myeloma, Relapse, Refractory, Aging, Co-morbidity
- Keywords
- Pomalidomide, Isatuximab, Dexamethasone, low dose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 26 Mar 2028 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Posted 20 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study aims to evaluate the safety and effectiveness of the combination of isatuximab, pomalidomide, and dexamethasone (Isa-Pd) for the treatment of relapsed or refractory multiple myeloma (RRMM), which refers to multiple myeloma that has returned or has not responded to prior treatment. The study will specifically investigate the impact of administering lower-than-standard doses of pomalidomide and dexamethasone. Using lower doses of pomalidomide and dexamethasone in this setting has not been approved by the Food and Drug Administration (FDA).
Detailed description
This study aims to address the challenges faced in selecting appropriate therapy for elderly or highly toxicity-vulnerable patients who are poor candidates for standard (full-dose) chemotherapy regimens. Traditional clinical trials often exclude these patients, limiting the generalizability of available data. This single-arm multicenter phase II study will enroll 49 older and/or toxicity-vulnerable patients with RRMM. The study will evaluate the safety and effectiveness of isatuximab when used in combination with pomalidomide and dexamethasone at lower than standard doses. The primary objective is to estimate the overall response rate (ORR), while secondary objectives include the estimation of additional measures of response, as well as measures of toxicity and tolerability. All participants in the trial will also be evaluated by Cancer and Aging Research Group Geriatric Assessments (CARG-GA) and patient- reported outcome (PRO) measures of quality of life (QOL). Biomarkers of aging and frailty will also be studied.
Duration of therapy:
The duration of study participation will depend on the response to the treatment. In the absence of treatment delays due to adverse events, treatment with Isa-Pd will generally continue until disease progression, unacceptable side effects, other illness or condition that prevents further study treatment, or a subject's decision to withdraw from the study. On average, subjects will most likely be treated for approximately 10 months on this study.
Duration of Follow-Up:
All participants, including those withdrawn for adverse events (AEs) will be followed after removal from study treatment until death or full subject withdrawal from the study for other reasons. Participants removed from the study treatment for unacceptable AEs will be followed for resolution or stabilization of the AEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Isatuximab, Drug: Pomalidomide, Drug: DexamethasoneSubjects with relapsed or refractory multiple myeloma receiving the study treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information (PHI). Consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Age ≥ 18 years at the time of consent.
- Documented symptomatic multiple myeloma that has previously responded to therapy (partial response or better) and is relapsed or relapsed and refractory to the last line of therapy.
- Patients must also be refractory to at least one prior line of therapy that includes an IMiD and/or a PI, and should have received at least 2 cycles of that regimen to be evaluable for refractoriness .
- If previously treated with an anti-CD38 containing regimen, the subject must have achieved at least a PR to that line of therapy and must not have received an anti- CD38 mAb for at least 6 months prior to enrollment.
Key exclusion criteria (7 listed)
- All subjects meeting any of the listed exclusion criteria at baseline with be excluded from study participation.
- Anti-myeloma treatment within 2 weeks of cycle 1 day 1
- Prior treatment with pomalidomide
- Any monoclonal antibody therapy within the previous 30-days
- Anti-CD38 monoclonal antibody therapy within the previous 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsatuximabPharmaceutical form: Solution for infusion. Route of administration: Intravenous 10 mg/kg will be administered intravenously once weekly during cycle 1 and every other week during each subsequent cycle. | Drug | Single Arm |
| PomalidomidePharmaceutical form: Pill for oral use. Route of administration: 3 mg Pomalidomide 3 mg pill will be taken by mouth once daily on days 1-21 of each 28-day cycle. | Drug | Single Arm |
| DexamethasonePharmaceutical form: Tablet for oral use Route of administration: Pill for oral use. Dexamethasone 20 mg tablet will be taken by mouth once per week. | Drug | Single Arm |
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to 12 weeks
Overall response rate (ORR) is defined as the percentage of participants achieving a partial response or better (≥PR) per IMWG criteria. The number and percentage of participants achieving at least a partial response were 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.
11 secondary outcomes
Treatment Related Adverse Events Rate
Time frame: Up to 12 weeks
Treatment Failure-free Survival (TFFS)
Time frame: Up to 3 years
Maximum Depth of Response
Time frame: Up to 12 weeks
Clinical Benefit Rate (CBR)
Time frame: Up to 12 weeks
Bone Marrow Minimal Residual Disease (MRD) Negativity
Time frame: Up to 12 weeks
Time to First Response
Time frame: Up to 12 weeks
Time to Best Response
Time frame: Up to 12 weeks
Duration of Response
Time frame: Up to 3 years
Progression-free Survival (PFS)
Time frame: Up to 3 years
Median Time to Next Treatment (TTNT)
Time frame: Up to 3 years
Overall Survival
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eben I Lichtman, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isatuximab, Pomalidomide and Dexamethasone in people with Multiple Myeloma and Relapse, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.