Trial · NCT05145400
Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
NCT05145400, Phase 2, Recruiting, UNC Lineberger Comprehensive Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma. Trials, record NCT05145400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05145400
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
- NCT number
- NCT05145400
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Multiple Myeloma, Cancer
- Interventions
- Isatuximab, Lenalidomide, Dexamethasone
- First posted
- 2021-12-06
- Last updated
- 2026-06-02
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | From Day 1 of study treatment up to 60 months | ORR, percentage of patients achieving a partial response or better per Revised Uniform Response Criteria by the International Myeloma Working Group (IMWG) criteria. Complete response (CR): Negative immunofixation of serum and urine, disappearance of soft tissue plasmacytomas, and \<5% plasma cells in bone marrow (BM). Stringent complete response (sCR): CR plus normal free light chains (FLC) ratio and absence of clonal plasma cells in BM biopsy. Very good partial response (VGPR):-Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M component plus urine M component \<100/24h. Partial response (PR) ≥50% reduction of serum M-protein \& reduction in 24-hour (24h) urinary M-protein by ≥90% or to \<200 mg/24h and if present at baseline, a ≥ 50% reduction in the size soft tissue plasmacytomas |
| Secondary | Treatment failure-free survival (TFFS) Time | From Day 1 of study treatment up to 60 months | Treatment failure-free survival (TFFS): The length of time from therapy start until therapy discontinuation for any reason, including disease progression, toxicity, or death. |
| Secondary | Progression-Free Survival (PFS) | From Day 1 of study treatment up to 60 months | PFS is the length of time from start of study treatment until day of confirmed progression or death. The (IMWG) defines progression as any one or more: Increase of 25% from lowest response value in Serum M-protein (absolute increase (AI) ≥ 0.5 g/dL); Serum M-protein increase ≥ 1 g/dL, if lowest M component was ≥ 5 g/dL; or Urine M-protein Difference of involved \& uninvolved FLC (free light chain) levels (AI \> 10 mg/dL) Bone marrow plasma cell percentage irrespective of baseline status (AI ≥ 10%) New lesion(s), ≥ 50% increase from nadir, or ≥ 50% increase in longest diameter of previous lesion \>1 cm in short axis; ≥ 50% increase in circulating plasma cells if only measure of disease New or definite increase in size of existing soft tissue plasmacytomas or bone lesions; Decrease in hemoglobin of ≥ 2 g/dL not related to therapy; Rise in serum creatinine by ≥2 mg/dL; Hyperviscosity related to serum paraprotein |
| Secondary | Maximum Depth of Response | From Day 1 of study treatment up to 60 months | Maximum depth of response (from PR to CR, including sCR) at any time will be determined based on IMWG criteria. Descriptions of partial, complete, or stringent-complete type treatment responses are summarized in the primary outcome section. |
| Secondary | Rate of achievement of bone marrow minimal residual disease (MRD) negativity | From Day 1 of study treatment up to 60 months | MRD status is determined by next-generation sequencing with a minimum sensitivity of 1 × 10-5. MRD refers to myeloma cells that are present in the bone marrow after a clinical response has been measured while signs and symptoms of MM are reduced or disappeared. |
| Secondary | Clinical Benefit Rate (minimal response (MR) + ORR) | From Day 1 of study treatment up to 60 months | The clinical benefit rate is the percentage of participants achieving overall response or minimal response. Description of overall response as defined as the percentage of subjects achieving a partial response or better (≥ PR) to study therapy at any time. Minimal response (MR) is ≥ 25% but ≤ 49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%. In addition to the above listed criteria, if present at baseline, a ≥ 50% reduction in the size (SPD) of soft tissue plasmacytomas is also required. |
| Secondary | Time to Response | From Day 1 of study treatment up to 60 months | Time to response is the length of time from start of study treatment until documentation of confirmed partial response (PR) or better based on IMWG criteria. Response description is given in the primary outcome section. |
| Secondary | Duration of Response | From Day 1 of study treatment up to 60 months | Duration of response is the length of time from achievement of PR or better until myeloma progression per IMWG criteria. PR description is given in the primary outcome section. |
| Secondary | Time to Next Treatment | From Day 1 of study treatment up to 60 months | Time to next treatment is the length of time time from start of study treatment to next MM treatment or death from any cause. |
| Secondary | Overall Survival | From Day 1 of study treatment up to 60 months | Overall Survival is the length of time from start of study treatment to death from any cause. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05145400
GET https://conductscience.org/api/trials/v1/NCT05145400/registered