Trial · NCT06209606
Pilot Study Using Changes in Serum BCMA to Determine Disease Progression in Multiple Myeloma
NCT06209606, Early phase 1, Recruiting, Oncotherapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study Using Changes in Serum BCMA to Determine Disease Progression in Multiple Myeloma. Trials, record NCT06209606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06209606
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study Using Changes in Serum BCMA to Determine Disease Progression in Multiple Myeloma
- NCT number
- NCT06209606
- Status
- Recruiting
- Phases
- Early phase 1
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Oncotherapeutics
- Conditions
- Multiple Myeloma
- Interventions
- Ruxolitinib Oral Tablet [Jakafi], Lenalidomide, Methylprednisolone
- First posted
- 2024-01-17
- Last updated
- 2024-12-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Disease Progression (TTP) | 54 months | * To establish the utility of using an increase in sBCMA levels \> 25% or IMWG criteria for disease progression to direct this therapeutic approach, TTP will be measured, where TTP is defined as a number of days between the start of treatment (cycle 1 day 1) and PD. PD is defined by either change in sBCMA (≥25% increase from its nadir levels) or by standard IMWG criteria (using sM-protein and SFLC assessments), whichever occurs first. PD will be confirmed by two consecutive tests. * Duration of response 1 (DOR1), defined as the time from the first response to progressive disease as determined by either changes in sBCMA or IMWG criteria (whichever occurs first) while patients are on ruxolitinib and methylprednisolone treatment * Duration of response 2 (DOR2), defined as the time from the first response to progressive disease as determined by standard IMWG criteria while patients on ruxolitinib, lenalidomide and methylprednisolone treatment |
| Secondary | Safety and Tolerability | 54 months | • Occurrence of adverse events throughout the study, graded via Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 criteria |
| Secondary | Efficacy and Overall Response | 54 months | * Efficacy of treatment will be assessed by the overall response rate (ORR; ORR = CR + VGPR + PR) and clinical benefit rate (CBR; CBR = CR + VGPR + PR + MR) of the doublet and triplet combinations * PFS1 as defined based on the length of time that patient was receiving therapy consisting of ruxolitinib with steroids until PD or death from any cause as determined by either an increase in sBCMA of ≥25% from its nadir or using IMWG criteria * PFS2 as defined based on the length of time that patient was receiving ruxolitinib, lenalidomide and steroid therapy to the time they reached disease progression as determined by the standard IMWG criteria or death from any cause * PFS from start of study treatment to disease progression as determined by the standard IMWG criteria or death from any cause including receiving treatment with ruxolitinib, lenalidomide and steroid |
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.
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/NCT06209606
GET https://conductscience.org/api/trials/v1/NCT06209606/registered