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Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma
NCT05346809 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to see if Isatuximab can alter the immune system in patients with multiple myeloma or lymphoma upon recovery from the autologous stem cell transplantation. The investigators will see if Isatuximab makes changes to the immune system so that upon recovery from the transplant, the immune system can fight the cancer. This study will have two arms. On one arm (control arm), participants will receive standard transplant procedures and on the other arm (experimental arm), participants will receive Isatuximab in addition to the standard transplant procedures. The assignment to these arms is done randomly (determined by chance, like flipping a coin) by a computer. Each participant will have about 66% chance of getting on the experimental arm and about 33% chance of getting on the control arm.
Conditions Studied
Interventions
- DRUG Isatuximab
- OTHER Standard Procedures
Study Locations (2)
Michigan
- Karmanos Cancer Institute — Detroit
New York
- Columbia University — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2023-03-31 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05346809
The ClinicalTrials.gov registry entry for NCT05346809 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Divaya Bhutani, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions — of which Isatuximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05346809 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Michigan, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05346809 about?
NCT05346809 is a clinical study titled "Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma". The purpose of this study is to see if Isatuximab can alter the immune system in patients with multiple myeloma or lymphoma upon recovery from the autologous stem cell transplantation. The investigators will see if Isatuximab makes changes to the immune system so that upon recovery from the transpla...
What is the current status of trial NCT05346809?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2023-03-31. Estimated completion is 2026-09.
What conditions does trial NCT05346809 study?
This clinical trial studies the following conditions: Multiple Myeloma, Lymphoma, Non-Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05346809?
The interventions under investigation include: Isatuximab (DRUG), Standard Procedures (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05346809?
This trial is sponsored by Divaya Bhutani, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05346809 being conducted?
This trial has 2 study locations across Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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