Elranatamab in Relapsed/Refractory Multiple Myeloma

NCT06711705 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 810312
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy of elranatamab alone in patients with relapsed and/or refractory Multiple myeloma who has previously received 1 to 3 combinations of treatment.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Elranatamab

Outcome Measures

Primary Outcomes (1)

• MRD negativity rate as best response

  MRD negativity rate as best response

  1 year of starting treatment

Secondary Outcomes (7)

• Sustained MRD negativity rate at 10^-5

  Through study completion, up to 5 years

• Overall response rate

  Within 1 year of treatment

• Complete response rate

  Within 1 year of treatment

• Progression free survival

  Through study completion, up to 5 years

• Duration of response

  Through study completion, up to 5 years

Other Outcomes (2)

• Soluble BCMA, T-cell immune phenotype

  1 year

• Overall MRD negativity rate at 10^-6

  1 year

Study Arms (1)

Elranatamab

EXPERIMENTAL

Treatment with elranatamab

Drug: Elranatamab

Interventions

Elranatamab DRUG

Subcutaneous injection of elranatamab. If patient achieves MRD negative remission, patient would enter treatment-free observation period with MRD monitoring.

Also known as: Elrexfio

Elranatamab

Eligibility Criteria

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

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Prior diagnosis of relapsed/refractory MM and have received 1 to 3 prior lines of therapy as defined by the IMWG criteria (Rajkumar et al., 2014) including anti-CD38 monoclonal antibody, proteosome inhibitor (PI), and immunomodulatory drug (IMiD), and BCMA-directed chimeric antigen receptor T-cell (CAR T-cell) therapy
• Refractory is defined as having disease progression while on therapy or within 60 days of last dose in any line, regardless of response.
• If participant has not received BCMA-directed CAR T-cell therapy, must be ineligible for CAR T-cell therapy or deferred such treatment by participant
• Aged greater or equal to 18 years
• Measurable disease as defined by any of the following:
• Serum M-protein level ≥ 0.5 g/dL by serum protein electrophoresis (SPEP), or
• Urine M-protein ≥ 200mg/24 hours by urine protein electrophoresis (UPEP), or
• Involved serum free light chain ≥ 10 mg/dL (≥100mg/L) AND an abnormal serum free light chain ratio in patients without measurable disease in the serum or urine
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Adequate hematological function defined as
• Absolute neutrophil count (ANC) ≥1,000/mm3 (G-CSF not permitted for at least 1 week prior to the first dose of elranatamab)
• Hemoglobin ≥8.0 g/dL (transfusion support is permitted if completed at least 1 week prior to planned start of dosing)
• Platelet count ≥75,000/mm3 or ≥50,000/mm3 if \>50% involvement with plasma cells in the screening bone marrow (transfusion support is permitted if completed at least 1 week prior to planned start of dosing)

You may not qualify if:

• Subjects with smoldering multiple myeloma, IgM multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, POEMS syndrome, and primary and secondary plasma cell leukemia, defined as circulating plasma cells ≥ 5%
• Extramedullary relapse who does not meet criteria for measurable disease as above
• Active malignancy other than Multiple Myeloma requiring treatment in the past 3 years, with the exception of successfully treated non-metastatic squamous or basal skin carcinoma
• Known CNS involvement by multiple myeloma
• Active, uncontrolled autoimmune disorders
• Active uncontrolled infection. Active infections must be resolved and/or controlled at least 14 days prior to enrollment.
• Radiation therapy within 2 weeks prior to study entry (bone lesions requiring radiation may be treated with limited \[ie, ≤25% of bone marrow in field\] radiation therapy during this period).
• Last systemic treatment within 2 weeks or 5 half lives, whichever is shorter. Subjects can receive a maximum of 160mg of dexamethasone or equivalent during screening, but at least 7 days prior to start of therapy.
• Last radiation treatment to multiple sites within 2 weeks and single site within 1 week
• History of autologous stem cell transplant within 100 days prior to study enrollment.
• History of allogeneic transplant within 1 year prior to study enrollment or active graft versus host disease.
• On immunosuppressive therapy for concurrent comorbid conditions
• Other major uncontrolled medical comorbidities that may put patients at risk of serious adverse event with treatment with study medication.
• Clinically significant, uncontrolled cardiac disease
• Grade ≥2 peripheral sensory or motor neuropathy

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92037, United States

RECRUITING

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

• Ah-Reum Jeong

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ah-Reum Jeong

CONTACT

(858) 822-6600; ajeong@health.ucsd.edu

Bone Marrow Transplant Research Team

CONTACT

(858) 822-5354; CancerCTO@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor, Medicine

Model Details: Phase II, single arm, open label clinical trial

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: December 2, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (1)