Clinical trial · Observational
Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant
NCT05271630CI-TRIAL-00104347active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to determine outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post Autologous Stem Cell Transplant (ASCT).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Stem Cell Transplant | Other | — | UNRESOLVED |
| Immunomodulatory Agent | Drug | — | UNRESOLVED |
| Proteasome Inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Single Maintenance After Autologous Stem Cell Transplant
- description
- Prospectively enrolled cohort of patients receiving single maintenance therapy with an immunomodulatory drug after Autologous Stem Cell Transplant for Multiple Myeloma
- interventionNames
- Other: Autologous Stem Cell Transplant
- Drug: Immunomodulatory Agent
- label
- Double Maintenance After Autologous Stem Cell Transplant
- description
- Prospectively enrolled cohort of patients receiving double maintenance therapy with the combination of an immunomodulatory drug and a proteasome inhibitor after Autologous Stem Cell Transplant for Multiple Myeloma.
- interventionNames
- Other: Autologous Stem Cell Transplant
- Drug: Immunomodulatory Agent
- Drug: Proteasome Inhibitor
Primary outcomes (1)
- measure
- MRD conversion rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All MM patients (18 years or greater) receiving autologous transplantation given as first line therapy (Melphalan at least 140 mg/m2) will be screened and enrolled in the study if they qualify and willing to participate. * Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed. * Histologically confirmed diagnosis of multiple myeloma. * Received high dose melphalan (≥ 140 mg/m2) followed by ASCT based on the institutional guidelines and within +60 and +180 after ASCT at the time of maintenance initiation. * Disease status must be very good partial response (VGPR), complete remission (CR), or stringent complete remission (sCR) per IMWG response criteria at time of study entry. * Measurable disease at diagnosis per IMWG criteria serum M spike ≥ 1g/dL, or Urine M protein ≥ 200 mg/24h or involved free light chain ≥ 100 mg/L with an abnormal ratio. * Patients must have the Clonoseq ID sample showing a trackable clone in bone marrow. Exclusion Criteria: * Patients who have purely non-secretory multiple myeloma (i.e., the absence of a measurable protein in serum by electrophoresis and immunofixation and the absence of Bence-Jones protein in the urine defined by use of electrophoresis and immunofixation) * Prior evidence of disease progression * Patients who have other malignancy associated with a high risk of progression in the next 2 years.
References
Publications (0)
Data not yet available
No reference posted for this study.