Personalized maintenance treatment for multiple myeloma after stem cell transplant

Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance

This study tests a personalized treatment plan using a new immunotherapy drug for people with multiple myeloma after a stem cell transplant to see if it helps them stay in remission longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Washington University School of Medicine (other)
• Drugs / interventions: elranatamab
• Locations: 1 site (St Louis, Missouri)
• Trial ID: NCT06483100 on ClinicalTrials.gov

What this trial studies

This study evaluates a personalized approach to maintenance treatment for patients with newly diagnosed multiple myeloma who have undergone autologous hematopoietic cell transplantation. It combines the immunotherapy drug elranatamab with peripheral blood-based clonotypic measurable residual disease (MRD) testing to tailor treatment based on individual patient responses. The goal is to generate efficacy data for this personalized maintenance strategy using bone marrow-based MRD testing to guide treatment decisions post-transplant.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed IgG or IgA multiple myeloma who have received autologous hematopoietic cell transplantation and have shown a partial response post-transplant.

Not a fit: Patients who are not newly diagnosed or those who do not meet the criteria for autologous hematopoietic cell transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and individualized maintenance therapies for patients with multiple myeloma, potentially improving long-term outcomes.

How similar studies have performed: Other studies have shown promise in using MRD-guided approaches in multiple myeloma, suggesting that this personalized strategy may be effective.

Eligibility criteria

Criteria for Pre-Screening Blood Draw

* Newly diagnosed multiple myeloma (either untreated or receiving first line therapy).
* Potentially eligible for autologous hematopoietic cell transplant (with or without tandem transplant) for frontline therapy.

Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* Inability to identify a trackable clonoSEQ ID.
* 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. Adjuvant endocrine therapy for hormone receptor-positive breast cancer is not exclusionary.
* 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.

Where this trial is running

St Louis, Missouri

• Washington University School of Medicine — St Louis, Missouri, United States (RECRUITING)

Study contacts

• Principal investigator: Michael Slade, M.D. — Washington University School of Medicine
• Study coordinator: Michael Slade, M.D.

Conditions: Multiple Myeloma, Maintenance, Stem cell transplant, Immunotherapy