Phase II MRD-Adapted Study of Elranatamab in Relapsed/Refractory

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

• Adequate renal function with estimated creatinine clearance (CrCl) ≥30 mL/min as calculated using Cockcroft-Gault equation.

• Adequate liver function defined as

∙ Aspartate and alanine aminotransferase (AST and ALT) ≤2.5 x upper limit of normal (ULN); ≤5.0 x ULN if there is liver involvement by the tumor.

‣ Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in case of bone metastasis).

‣ Total bilirubin ≤2.0 mg/dL, except in patients with Gilbert Syndrome who must have a total bilirubin less than 3.0 mg/dL.

⁃ Able to receive outpatient treatment of elranatamab by meeting the following criteria:

• Lives within 30minutes from the site of medication administration

∙ Reliable caregiver present, who is able to watch participant continuously for at least until 48 hours after administration of first full treatment dose

∙ No history of grade 3-4 CRS or grade 3-4 ICANS from other immune effector cell or bispecific antibody therapies

⁃ Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1

⁃ Serum pregnancy test (for females of childbearing potential) negative at screening.

⁃ a. Female patients of non-childbearing potential must meet at least 1 of the following criteria: i. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.

⁃ ii. Have undergone a documented hysterectomy and/or bilateral oophorectomy. iii. Have medically confirmed ovarian failure. b. All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential.

⁃ Agreement to adhere to Lifestyle Considerations (see section 5.3 and Appendix 2) throughout study duration

Locations
United States
California
University of California San Diego
RECRUITING
La Jolla
Contact Information
Primary
Ah-Reum Jeong
ajeong@health.ucsd.edu
(858) 822-6600
Backup
Krisma Montalvo
k1montalvo@health.ucsd.edu
(858) 822-5364
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2030-12
Participants
Target number of participants: 33
Treatments
Experimental: Elranatamab
Treatment with elranatamab
Related Therapeutic Areas
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov