Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance

NCT06483100 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 202409141
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Multiple Myeloma

Keywords

Maintenance; Stem cell transplant; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS)

  Progression-free survival (PFS) is defined as time to progression or death.

  Through completion of follow-up (up to 5 years)

• Proportion of patients achieving MRD negativity at the 10^-5 threshold per the clonoSEQ assay

  Through completion of end of study visit (up to 36 months)

Secondary Outcomes (9)

• Event-free survival (EFS)

  Through completion of follow-up (up to 5 years)

• Time to next therapy

  Through completion of follow-up (up to 5 years)

• Maximum depth of response by IMWG criteria

  Through completion of end of study visit (up to 36 months)

• Proportion of patients achieving sustained MRD-negativity at the 10^-5 threshold per the clonoSEQ assay for at least 12 months

  Through completion of end of study visit (up to 36 months)

• Proportion of patients discontinuing therapy per MRD-guided protocol

  Through completion of treatment (up to 36 months)

Study Arms (1)

Elranatamab

EXPERIMENTAL

Patients will receive at least 12 months of maintenance elranatamab therapy. Patients will have MRD testing within clonoSEQ every 6 months. If 2 consecutive tests are negative, elranatamab will be stopped and the patient will go on observation schedule. Once a patient starts the observation schedule, standard disease monitoring will be performed every 3 months and bone marrow-based MRD will be performed every 6 months until MRD recurrence, disease progression or end of study period (patients' on-study status will be a maximum of 36 months for treatment and intensive observation combined). Patients who experience MRD recurrence will be re-treated per study protocol. A patient may move back to the observation schedule after treatment re-initiation provided the same criteria as above are met (2 consecutive negative MRD tests). Patients who are determined to have progressive disease per IMWG criteria (whether on treatment or observation schedule) will transition off study.

Drug: Elrantamab; Device: clonoSEQ

Interventions

Elrantamab DRUG

\- Elranatamab will be dosed in 28-day cycles as follows: * C1D1: 12 mg SC priming dose * C1D3: 32 mg SC priming dose * C1D8, C1D15, C1D22: 76 mg SC * Cycle 2-Cycle 7: 76 mg SC on D1 and D15 * Cycle 8 and subsequent cycles: 76 mg SC on D1

Elranatamab

clonoSEQ DEVICE

FDA approved MRD testing

Elranatamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Ability to understand and willingness to sign an IRB approved written informed consent document. (Legally authorized representatives may sign and give informed consent on behalf of study participants.)
• Received autologous hematopoietic cell transplantation (with or without tandem transplant) as part of frontline therapy for newly diagnosed IgG or IgA multiple myeloma. Frontline therapy in this setting is defined as treatment received prior to first relapse and may include multiple lines of therapy per the Rajkumar et al definition if treatment changes were made for either toxicity or inadequate response to initial induction.
• Received frontline treatment with at least a triplet regimen including a PI and an IMID (+/- an anti-CD38 antibody)
• Disease response of ≥ partial response (PR) by IMWG criteria at time of study screening (post-transplant).
• MRD-positive on Day 100 landmark assessment (80 to 160 days after AHCT), defined as \>1 x 10-5 myeloma cells/cell by clonoSEQ assay (Adaptive Biotechnologies, Seattle, WA) performed on bone marrow aspirate.
• ECOG performance status ≤ 2
• All toxicities from prior treatment should have resolved to Grade ≤ 1 prior to enrollment.
• Adequate bone marrow and organ function within 28 days prior to start of treatment as defined below:
• Platelets ≥ 75 k/cumm
• Absolute neutrophil count ≥ 1.0 k/cumm
• Hemoglobin ≥ 8 g/dL without the use of growth factors or transfusion for at least 2 weeks.
• Total bilirubin ≤ 2 × upper limit of normal (ULN; ≤ 3 x ULN if documented Gilbert's syndrome)
• Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN
• Creatinine clearance ≥ 30 ml/min.

You may not qualify if:

• Inability to identify a trackable clonoSEQ ID.
• Currently receiving any other investigational agents.
• Prior BCMA-based treatment.
• CNS involvement of disease.
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to elranatamab or other agents used in the study.
• Uncontrolled intercurrent illness including, but not limited to, plasma cell leukemia, POEMS syndrome, systemic amyloidosis, ongoing or active infection (bacterial, fungal, or viral).
• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to first dose of elranatamab.
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Comprehensive Cancer Network: collaborator
• Pfizer: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Michael Slade, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Slade, M.D.

CONTACT

314-454-8304; sladem@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 3, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Interested parties should contact the investigator to discuss access to de-identified datasets.

Locations

US (1)