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Elranatamab for Multiple Myeloma

Phase 2
Waitlist Available
Led By Michael Slade, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Criteria for Pre-Screening Blood Draw
* Newly diagnosed with IgG or IgA multiple myeloma (either untreated or receiving first line therapy).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (up to 5 years)
Awards & highlights

Summary

This study evaluates an individualized approach combining highly active maintenance treatment with elranatamab with peripheral blood-based clonotypic measurable residual disease (MRD) testing in patients with newly diagnosed multiple myeloma. The overall goal is to generate efficacy and tolerability data for a personalized maintenance approach using peripheral blood-based clonotypic mass spectrometry MRD testing (the EasyM assay) to guide post-autologous hematopoietic cell transplant (AHCT) maintenance with elranatamab for this patient population.

Who is the study for?
This trial is for newly diagnosed multiple myeloma patients who have undergone a stem cell transplant. It's designed to see if monitoring their blood with a special test (EasyM assay) and treating them with elranatamab can help keep the cancer in check.
What is being tested?
The study tests whether using the EasyM assay to monitor blood for cancer signs after a stem cell transplant, combined with maintenance therapy using elranatamab, is effective and tolerable for multiple myeloma patients.
What are the potential side effects?
Elranatamab may cause side effects such as infusion reactions, fatigue, immune system suppression leading to infections, or potential allergic responses. The severity of side effects can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (up to 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (up to 5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-free survival (EFS)
Secondary study objectives
Incidence and severity of treatment-related adverse events by CTCAE v5
Maximum depth of response by IMWG criteria
Overall survival (OS)
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ElranatamabExperimental Treatment3 Interventions
Patients on elranatamab will have EasyM test every 3 months. If 2 consecutive tests are negative, will have bone marrow biopsy (BMBX) with clonoSEQ to verify MRD status. If negative, drug will be stopped \& will go on intensive observation schedule. If testing is positive, the patient will continue drug until 2 additional tests are negative, followed by repeat BMBX. If BM MRD testing is equivocal, physician may re-test with 2nd BMBX, continue drug, or go to intensive observation. Intensive observation schedule: Blood-based MRD testing \& disease monitoring performed monthly x 3 months, every 2 months x 6 months, \& every 3 months until MRD recurrence or end of study (patients on-study maximum of 36 months). On observation, any positive peripheral blood MRD test (confirmed 2 weeks later) will lead to drug re-initiation. A patient may go back to observation after drug re-initiation provided 2 consecutive negative MRD tests drawn 3 months apart \& confirmatory negative BMBX.

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,970 Previous Clinical Trials
2,313,807 Total Patients Enrolled
34 Trials studying Multiple Myeloma
2,267 Patients Enrolled for Multiple Myeloma
National Comprehensive Cancer NetworkNETWORK
118 Previous Clinical Trials
7,825 Total Patients Enrolled
1 Trials studying Multiple Myeloma
11 Patients Enrolled for Multiple Myeloma
Rapid NovorUNKNOWN
~43 spots leftby Sep 2031
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