RECRUITING

Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance

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Conditions

Multiple MyelomaMaintenanceStem cell transplantImmunotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 data for a personalized maintenance approach using bone marrow-based MRD testing (clonoSEQ) to guide post-autologous hematopoietic cell transplant (AHCT) maintenance with elranatamab for this patient population.

Official Title

Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance

Quick Facts

Study Start:2024-12-20
Study Completion:2031-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06483100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Received autologous hematopoietic cell transplantation (with or without tandem transplant) as part of frontline therapy for newly diagnosed IgG or IgA multiple myeloma.
  2. * Received induction treatment with at least a triplet regimen including a PI and an IMID (+/- an anti-CD38 antibody)
  3. * Disease response of ≥ partial response (PR) by IMWG criteria at time of study screening (post-transplant).
  4. * MRD-positive on Day 100 landmark assessment (80 to 140 days after AHCT), defined as \>1 x 10-5 myeloma cells/cell by clonoSEQ assay (Adaptive Biotechnologies, Seattle, WA) performed on bone marrow aspirate.
  5. * ECOG performance status ≤ 2
  6. * All toxicities from prior treatment should have resolved to Grade ≤ 1 prior to enrollment.
  7. * Adequate bone marrow and organ function within 28 days prior to start of treatment as defined below:
  8. * Platelets ≥ 75 k/cumm
  9. * Absolute neutrophil count ≥ 1.0 k/cumm
  10. * Hemoglobin ≥ 8 g/dL without the use of growth factors or transfusion for at least 2 weeks.
  11. * Total bilirubin ≤ 2 × upper limit of normal (ULN; ≤ 3 x ULN if documented Gilbert's syndrome)
  12. * Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN
  13. * Creatinine clearance ≥ 30 ml/min.
  14. * The effects of elranatamab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 5 months after end of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
  1. * Inability to identify a trackable clonoSEQ ID.
  2. * A history of other malignancy with the exception of non-melanoma skin cancers, low or very low risk prostate cancer by NCCN criteria status post definitive therapy or currently on active surveillance, and malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
  3. * Currently receiving any other investigational agents.
  4. * Prior BCMA-based treatment.
  5. * CNS involvement of disease.
  6. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to elranatamab or other agents used in the study.
  7. * Uncontrolled intercurrent illness including, but not limited to, plasma cell leukemia, POEMS syndrome, systemic amyloidosis, ongoing or active infection (bacterial, fungal, or viral).
  8. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to first dose of elranatamab.
  9. * HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.

Contacts and Locations

Study Contact

Michael Slade, M.D.
CONTACT
314-454-8304
sladem@wustl.edu

Principal Investigator

Michael Slade, M.D.
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Michael Slade, M.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-20
Study Completion Date2031-12-31

Study Record Updates

Study Start Date2024-12-20
Study Completion Date2031-12-31

Terms related to this study

Keywords Provided by Researchers

  • Maintenance
  • Stem cell transplant
  • Immunotherapy

Additional Relevant MeSH Terms

  • Multiple Myeloma