RECRUITING

Elranatamab in Relapsed/Refractory Multiple Myeloma

Conditions

Quick Navigation

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

Official Title

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

Quick Facts

Study Start:2024-12-18

Study Completion:2030-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06711705

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 Criteria	Exclusion Criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. 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 1. Refractory is defined as having disease progression while on therapy or within 60 days of last dose in any line, regardless of response. 2. 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 4. Aged greater or equal to 18 years 5. Measurable disease as defined by any of the following: 1. Serum M-protein level ≥ 0.5 g/dL by serum protein electrophoresis (SPEP), or 2. Urine M-protein ≥ 200mg/24 hours by urine protein electrophoresis (UPEP), or 3. 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 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 7. Adequate hematological function defined as 1. Absolute neutrophil count (ANC) ≥1,000/mm3 (G-CSF not permitted for at least 1 week prior to the first dose of elranatamab) 2. Hemoglobin ≥8.0 g/dL (transfusion support is permitted if completed at least 1 week prior to planned start of dosing) 3. 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) 8. Adequate renal function with estimated creatinine clearance (CrCl) ≥30 mL/min as calculated using Cockcroft-Gault equation. 9. Adequate liver function defined as 1. 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. 2. Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in case of bone metastasis). 3. Total bilirubin ≤2.0 mg/dL, except in patients with Gilbert Syndrome who must have a total bilirubin less than 3.0 mg/dL. 10. Able to receive outpatient treatment of elranatamab by meeting the following criteria: 1. Lives within 30minutes from the site of medication administration 2. Reliable caregiver present, who is able to watch participant continuously for at least until 48 hours after administration of first full treatment dose 3. No history of grade 3-4 CRS or grade 3-4 ICANS from other immune effector cell or bispecific antibody therapies 11. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1 12. Serum pregnancy test (for females of childbearing potential) negative at screening. 13. Agreement to adhere to Lifestyle Considerations (see section 5.3 and Appendix 2) throughout study duration	1. 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% 2. Extramedullary relapse who does not meet criteria for measurable disease as above 3. 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 4. Known CNS involvement by multiple myeloma 5. Active, uncontrolled autoimmune disorders 6. Active uncontrolled infection. Active infections must be resolved and/or controlled at least 14 days prior to enrollment. 7. 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). 8. 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. 9. Last radiation treatment to multiple sites within 2 weeks and single site within 1 week 10. History of autologous stem cell transplant within 100 days prior to study enrollment. 11. History of allogeneic transplant within 1 year prior to study enrollment or active graft versus host disease. 12. On immunosuppressive therapy for concurrent comorbid conditions 13. Other major uncontrolled medical comorbidities that may put patients at risk of serious adverse event with treatment with study medication. 14. Clinically significant, uncontrolled cardiac disease 15. Grade ≥2 peripheral sensory or motor neuropathy 16. History of Guillan-Barre syndrome 17. Other surgical (including major surgery within 14 days prior to enrollment) or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 18. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). 19. Pregnancy or lactation 20. Known or suspected hypersensitivity to the study intervention or any of its excipients.

Inclusion Criteria

Exclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. 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
1. Refractory is defined as having disease progression while on therapy or within 60 days of last dose in any line, regardless of response.
2. 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
4. Aged greater or equal to 18 years
5. Measurable disease as defined by any of the following:
1. Serum M-protein level ≥ 0.5 g/dL by serum protein electrophoresis (SPEP), or
2. Urine M-protein ≥ 200mg/24 hours by urine protein electrophoresis (UPEP), or
3. 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
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
7. Adequate hematological function defined as
1. Absolute neutrophil count (ANC) ≥1,000/mm3 (G-CSF not permitted for at least 1 week prior to the first dose of elranatamab)
2. Hemoglobin ≥8.0 g/dL (transfusion support is permitted if completed at least 1 week prior to planned start of dosing)
3. 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)
8. Adequate renal function with estimated creatinine clearance (CrCl) ≥30 mL/min as calculated using Cockcroft-Gault equation.
9. Adequate liver function defined as
1. 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.
2. Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in case of bone metastasis).
3. Total bilirubin ≤2.0 mg/dL, except in patients with Gilbert Syndrome who must have a total bilirubin less than 3.0 mg/dL.
10. Able to receive outpatient treatment of elranatamab by meeting the following criteria:
1. Lives within 30minutes from the site of medication administration
2. Reliable caregiver present, who is able to watch participant continuously for at least until 48 hours after administration of first full treatment dose
3. No history of grade 3-4 CRS or grade 3-4 ICANS from other immune effector cell or bispecific antibody therapies
11. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
12. Serum pregnancy test (for females of childbearing potential) negative at screening.
13. Agreement to adhere to Lifestyle Considerations (see section 5.3 and Appendix 2) throughout study duration

1. 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%
2. Extramedullary relapse who does not meet criteria for measurable disease as above
3. 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
4. Known CNS involvement by multiple myeloma
5. Active, uncontrolled autoimmune disorders
6. Active uncontrolled infection. Active infections must be resolved and/or controlled at least 14 days prior to enrollment.
7. 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).
8. 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.
9. Last radiation treatment to multiple sites within 2 weeks and single site within 1 week
10. History of autologous stem cell transplant within 100 days prior to study enrollment.
11. History of allogeneic transplant within 1 year prior to study enrollment or active graft versus host disease.
12. On immunosuppressive therapy for concurrent comorbid conditions
13. Other major uncontrolled medical comorbidities that may put patients at risk of serious adverse event with treatment with study medication.
14. Clinically significant, uncontrolled cardiac disease
15. Grade ≥2 peripheral sensory or motor neuropathy
16. History of Guillan-Barre syndrome
17. Other surgical (including major surgery within 14 days prior to enrollment) or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
18. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
19. Pregnancy or lactation
20. Known or suspected hypersensitivity to the study intervention or any of its excipients.

Contacts and Locations

Study Contact

Ah-Reum Jeong

CONTACT

(858) 822-6600

ajeong@health.ucsd.edu

Krisma Montalvo

CONTACT

(858) 822-5364

k1montalvo@health.ucsd.edu

Principal Investigator

Ah-Reum Jeong

PRINCIPAL_INVESTIGATOR

University of California, San Diego

Study Locations (Sites)

University of California San Diego

La Jolla, California, 92037

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Ah-Reum Jeong, PRINCIPAL_INVESTIGATOR, University of California, San Diego

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 Date2024-12-18

Study Completion Date2030-12

Study Record Updates

Study Start Date2024-12-18

Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

Multiple Myeloma
Elranatamab

Additional Relevant MeSH Terms

Multiple Myeloma