A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment

Overview

About this study

The purpose of this study is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and effectiveness of different doses of elranatamab, as well as different intervals between doses. Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)

- Measurable disease, as defined by at least 1 of the following:

1. Serum M-protein >0.5 g/dL by SPEP

2. Urinary M-protein excretion >200 mg/24 hours by UPEP

3. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin
kappa to lambda FLC ratio

- Refractory to at least one IMiD

- Refractory to at least one PI

- Refractory to at least one anti-CD38 antibody

- Relapsed/refractory to last anti-myeloma regimen

- ECOG performance status ≤1

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

- Not pregnant and willing to use contraception

Exclusion Criteria:

- Smoldering multiple myeloma

- Active Plasma cell leukemia

- POEMS syndrome

- Amyloidosis

- Waldenström's macroglobulinemia

- Known active CNS involvement or clinical signs of myelomatous meningeal involvement

- Stem cell transplant within 12 weeks prior to enrollment or active GVHD

- Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or
viral infection

- Any other active malignancy within 3 years prior to enrollment, except for adequately
treated basal cell or squamous cell skin cancer, or carcinoma in situ or Stage 0/1
malignancy with minimal risk of recurrence per investigator.

- Previous treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy.

- Live attenuated vaccine within 4 weeks of the first dose

- Previous administration with an investigational drug within 30 days or 5 half-lives
preceding the first dose of study intervention used in this study (whichever is
longer)

- Known or suspected hypersensitivity to the study intervention, or any of its
excipients or unable to tolerate systemic corticosteroids at doses planned to be
administered in the study Part 3

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 3/22/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Rafael Fonseca, M.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Rafael Fonseca, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Clinical Trials