Trial · NCT07605416
Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial
NCT07605416, Phase 2, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial. Trials, record NCT07605416. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07605416
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial
- NCT number
- NCT07605416
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 74 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Plasma Cell Leukemia
- Interventions
Autologous Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Carfilzomib, Computed Tomography, Daratumumab and Recombinant Human Hyaluronidase, Dexamethasone, Fludeoxyglucose F-18, Lenalidomide, Magnetic Resonance Imaging, Melphalan, Plerixafor, Positron Emission Tomography, Recombinant Granulocyte Colony-Stimulating Factor, Stem Cell Isolation, Teclistamab, Transthoracic Echocardiography Test
- First posted
- 2026-05-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival (OS) | From randomization to the time of death due to any cause, assessed up to 5 years | The time to event outcome of overall survival will be evaluated and compared using a log-rank test to compare differences between arms. OS distributions will be evaluated graphically using the methods of Kaplan and Meier, along with estimation of the 3-year OS rates with corresponding 95% confidence intervals and other time points of interest. In a secondary manner, Cox regression models will also be used to evaluate differences in OS between treatment arms when adjusting for factors of interest as well as stratifying on the stratification factors including prior treatment status and t(11;14) status. |
| Secondary | Incidence of adverse events | Up to 5 years | Adverse events (AEs) will be summarized per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5, and where toxicities will be defined as adverse events that are deemed to be at least possibly treatment-related (i.e., attribution of "possibly", "probably", or "definite"). Note that some AEs will be defined using other criteria where specified. The maximum grade for each type of treatment-related AE will be recorded for each patient, and the frequency of each will be summarized across all patients for the induction phase, and by treatment arm for the consolidation and maintenance phases of treatment. Frequency tables and graphical evaluations of AEs and treatment-related AEs will be summarized and evaluated to assess if there are any patterns or differences in the rates or types of AEs including, but not limited to, AEs of special interest including cytokine release syndrome, neurotoxicity, and second primary malignancies. |
| Secondary | Progression free survival (PFS) | From randomization to the time of progression and/or death due to any cause, assessed up to 5 years | Will use Kaplan-Meier analyses and Cox regression models to evaluate this endpoint and how the PFS distributions differ between the treatment arms. |
| Secondary | Overall response rate | Up to 5 years | Overall response rate will be summarized for each of the treatment arms and defined as the number of patients who achieve at least a partial response to therapy divided by the total number of patients treated on that arm. Will summarize the incidence and depth of objective response both post-induction as well as post-consolidation. Response rates will be calculated along with 95% binomial confidence intervals for each of the t(11;14) subjects and treatment arms. |
| Other | Minimal residual disease (MRD) negativity | At baseline, post-induction, post-transplant, post-consolidation, and post-maintenance | MRD negativity will be evaluated over the course of the trial when a bone marrow biopsy and aspirate is obtained to confirm complete response or better and will be summarized based on treatment arm and t(11;14) status. Repeated measures models will also be used to evaluate changes over time along with graphical analyses to assess patterns or differences based on subgroup and/or treatment and how these relate to key therapeutic milestones. Time-dependent covariate analyses will also be used to explore the relationship of this outcome and how these longitudinal outcomes may correspond to PFS and OS in these patients. |
Source ClinicalTrials.gov
Outcomes0
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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07605416
GET https://conductscience.org/api/trials/v1/NCT07605416/registered