Trial · NCT04430894
KRDI in Transplant-Eligible MM
NCT04430894, Phase 2, Active not recruiting, Massachusetts General Hospital; results first posted 2023-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. KRDI in Transplant-Eligible MM. Trials, record NCT04430894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04430894
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- KRDI in Transplant-Eligible MM
- NCT number
- NCT04430894
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Multiple Myeloma
- Interventions
- Carfilzomib, Isatuximab, Lenalidomide, Dexamethasone
- First posted
- 2020-06-12
- Last updated
- 2026-10-06
- Results first posted
- 2023-10-26
- Limitations and caveats
Results up to cycle 6/8 of KRDI are currently available and entered in CT.gov, including the primary endpoint and secondary endpoints that can be reported at this time. Data after the beginning of maintenance therapy (post-cycle 6 for patients who had stem cell transplants, and post-cycle 8 for patients who deferred stem cell transplant), including adverse event data, is still being collected and analyzed as of August 2023.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR + Stringent CR) Rate | 112 Days | Percentage of patients who achieved a complete response (CR) or stringent CR (sCR) per International Myeloma Working Group (IMWG) Uniform Response criteria after 4 cycles of of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI). IMWG criteria define a CR as "Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow" and an sCR as "CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence." |
| Secondary | Overall Response Rate After 4 Cycles Induction Therapy | 112 days (4 cycles) | Overall response rate will be the percentage of patients who achieve at least partial response (PR) per International Myeloma Working Group (IMWG) Uniform Response criteria after 4 cycles of of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI). The IMWG response criteria define a PR as: \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h, OR If the serum and urine M-protein are unmeasurable, a \> 50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, OR If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \> 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \> 30%. In addition to the above listed criteria, if present at baseline, a \> 50% reduction in the size of soft tissue plasmacytomas is also required for a partial response. |
| Secondary | Minimal Residual Disease (MRD) Rate After 4 Cycles Induction Therapy | 112 Days (4 Cycles) | MRD is the small number myeloma cells surviving in the bone marrow after a clinical response has been measured and the patient is in remission. MRD negativity will be determined by deep sequencing of genomic deoxyribonucleic acid from bone marrow samples using rearranged Ig locus-specific primers (Adaptive, Seattle, WA). The MRD rate after 4 cycles of of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI) is the percentage of patients who are MRD negative at 10\^(-5) and 10\^(-6), meaning that no MRD was detected in samples of 100,000 cells and 1,000,000 cells, respectively. |
| Secondary | Minimal Residual Disease (MRD) Rate at 10^(-5) in Patients Receiving Upfront Stem Cell Transplant | 168 Days (6 cycles, upfront transplant) | MRD is the small number myeloma cells surviving in the bone marrow after a clinical response has been measured and the patient is in remission. MRD negativity will be determined by deep sequencing of genomic deoxyribonucleic acid from bone marrow samples using rearranged Ig locus-specific primers (Adaptive, Seattle, WA). The MRD rate is the percentage of patients who are MRD negative at 10\^(-5), meaning that no MRD was detected in a sample of 100,000 cells. MRD status was assessed after 4 cycles of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI) induction, stem cell transplant, and 2 cycles of KRDI consolidation therapy (6 cycles total.) |
| Secondary | Minimal Residual Disease (MRD) Rate at 10^(-5) in Patients Deferring Stem Cell Transplant | 224 Days (8 cycles transplant-deferred) | MRD is the small number myeloma cells surviving in the bone marrow after a clinical response has been measured and the patient is in remission. MRD negativity will be determined by deep sequencing of genomic deoxyribonucleic acid from bone marrow samples using rearranged Ig locus-specific primers (Adaptive, Seattle, WA). The MRD rate is the percentage of patients who are MRD negative at 10\^(-5), meaning that no MRD was detected in a sample of 100,000 cells. MRD status was assessed after 4 cycles of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI) induction, stem cell collection, and 4 additional cycles of KRDI (8 cycles total). |
| Secondary | Progression Free Survival at 12 Months | 12 months | Progression free survival (PFS) is defined as the time between the start of treatment and disease progression or death due to any cause. PFS at 12 months is the percentage of patients who were alive and without disease progression 12 months after initiating treatment with of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI). |
| Secondary | Overall Survival at 12 Months | 12 months | Overall survival (OS) is defined as the time between the start of treatment and death due to any cause. OS at 12 months is the percentage of patients who were alive 12 months after initiating treatment with of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI). |
| Secondary | Complete Response Rate in Patients With Upfront Stem Cell Transplant | 168 Days | Percentage of patients who achieved a complete response (CR) or stringent CR (sCR) per International Myeloma Working Group (IMWG) Uniform Response criteria after 4 cycles of of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI), stem cell transplant, and 2 cycles of KRDI consolidation (6 cycles total). IMWG criteria define a CR as "Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow" and an sCR as "CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence." |
| Secondary | Complete Response Rate in Patients Deferring Stem Cell Transplant | 224 Days | Percentage of patients who achieved a complete response (CR) or stringent CR (sCR) per International Myeloma Working Group (IMWG) Uniform Response criteria after 4 cycles of of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI), stem cell collection, and 4 additional cycles of KRDI after deferring stem cell transplant (8 cycles total). IMWG criteria define a CR as "Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow" and an sCR as "CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence." |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response (CR + Stringent CR) Rate | 112 Days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Response Rate After 4 Cycles Induction Therapy | 112 days (4 cycles) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Minimal Residual Disease (MRD) Rate After 4 Cycles Induction Therapy | 112 Days (4 Cycles) | After cycle 4, 28 patients out of 47 patients evaluable for response had evaluable MRD data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Minimal Residual Disease (MRD) Rate at 10^(-5) in Patients Receiving Upfront Stem Cell Transplant | 168 Days (6 cycles, upfront transplant) | Of all patients enrolled to the main arm of the protocol (induction), 47 were evaluable for response. Of these 47 patients, 5 received upfront stem cell transplant. All five patients receiving upfront SCT had evaluable MRD results. | percentage of participants | NUMBER |
| SECONDARY | Minimal Residual Disease (MRD) Rate at 10^(-5) in Patients Deferring Stem Cell Transplant | 224 Days (8 cycles transplant-deferred) | Of all patients enrolled to the main arm of the protocol (induction), 47 were evaluable for response. Of these 47 patients, 42 deferred stem cell transplant. 35 of these 42 patients had evaluable MRD results. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival at 12 Months | 12 months | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival at 12 Months | 12 months | percentage of participants | NUMBER | |
| SECONDARY | Complete Response Rate in Patients With Upfront Stem Cell Transplant | 168 Days | Of all patients enrolled to the main arm of the protocol (induction), 47 were evaluable for response. Of these 47 patients, 5 received upfront stem cell transplant. | percentage of participants | NUMBER |
| SECONDARY | Complete Response Rate in Patients Deferring Stem Cell Transplant | 224 Days | Of all patients enrolled to the main arm of the protocol (induction), 47 were evaluable for response. Of these 47 patients, 42 deferred stem cell transplant. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response (CR + Stringent CR) Rate | Induction | 19 | Participants | ||
| Overall Response Rate After 4 Cycles Induction Therapy | Induction | 47 | Participants | ||
| Minimal Residual Disease (MRD) Rate After 4 Cycles Induction Therapy | Induction | MRD negative at 10^(-5) | 12 | Participants | |
| Minimal Residual Disease (MRD) Rate After 4 Cycles Induction Therapy | Induction | MRD negative at 10^(-6) | 9 | Participants | |
| Minimal Residual Disease (MRD) Rate at 10^(-5) in Patients Receiving Upfront Stem Cell Transplant | Upfront Stem Cell Transplant (4 Cycles Induction Therapy, SCT, and 2 Cycles Consolidation Therapy) | 20 | percentage of participants | ||
| Minimal Residual Disease (MRD) Rate at 10^(-5) in Patients Deferring Stem Cell Transplant | Deferred Stem Cell Transplant (4 Cycles, Stem Cell Collection, 4 Additional Cycles) | 26 | Participants | ||
| Progression Free Survival at 12 Months | Induction | 97.9 | 95% Confidence Interval 95.9 to 99.7 | percentage of participants | |
| Overall Survival at 12 Months | Induction | 97.9 | 95% Confidence Interval 86.1 to 99.7 | percentage of participants | |
| Complete Response Rate in Patients With Upfront Stem Cell Transplant | Upfront Stem Cell Transplant (4 Cycles Induction Therapy, SCT, and 2 Cycles Consolidation Therapy) | 80 | percentage of participants | ||
| Complete Response Rate in Patients Deferring Stem Cell Transplant | Deferred Stem Cell Transplant (4 Cycles, Stem Cell Collection, 4 Additional Cycles) | 67 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Induction | 50 | |
| Overall Study | COMPLETED | Induction | 47 | |
| Overall Study | NOT COMPLETED | Induction | 3 |
Source ClinicalTrials.gov
Adverse events197
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Induction | 3 | 50 | |
| other | Agitation | Psychiatric disorders | Induction | 1 | 50 | |
| other | Alanine aminotransferase increased | Investigations | Induction | 24 | 50 | |
| other | Alkaline phosphatase increased | Investigations | Induction | 17 | 50 | |
| other | Allergic Reaction | Immune system disorders | Induction | 1 | 50 | |
| other | Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Induction | 1 | 50 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Induction | 1 | 50 | |
| other | Anemia | Blood and lymphatic system disorders | Induction | 21 | 50 | |
| other | Ankle fracture | Injury, poisoning and procedural complications | Induction | 1 | 50 | |
| other | Anorexia | Metabolism and nutrition disorders | Induction | 3 | 50 |
1 to 10 of 197Source ClinicalTrials.gov
See all 197 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction | 1 | 50 |
| Total, other adverse events | Induction | 49 | 50 |
| Total, serious adverse events | Induction | 8 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38677302 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04430894
GET https://conductscience.org/api/trials/v1/NCT04430894/events?page=2