SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM


About this study

The purpose of this study is to demonstrate the efficacy non-inferiority between isatuximab SC and isatuximab IV in combination with pomalidomide and dexamethasone (Pd), and to demonstrate the pharmacokinetic (PK) non-inferiority between isatuximab SC and isatuximab IV in combination with Pd. 

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:

-Participants with multiple myeloma who have received at least one prior line of therapy
including lenalidomide and a proteasome inhibitor, and with measurable serum M-protein (≥
0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC)
assay (Involved FLC assay ≥ 10 mg/dL and abnormal serum FLC ratio (< 0.26 or > 1.65)).

Exclusion Criteria:

- Participants less than 18 years old, participants with Eastern Cooperative Oncology
Group performance status more than 2.

- Primary refractory multiple myeloma participants.

- Participants refractory to anti-CD38 with a wash-out period inferior to 9 months or
intolerant to anti-CD38 mAb agents.

- Prior therapy with pomalidomide.

- Participants with inadequate biological tests.

- Significant cardiac dysfunction.

- Participants diagnosed or treated for another cancer within 3 years prior to
randomization with the exception of complete resection of basal cell carcinoma or
squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate
cancer after curative therapy.

- Concomittant plasma cell leukemia.

- Active primary amyloid-light (AL) amyloidosis.

- Known acquired immunodeficiency syndrome (AIDS)-related illness or known human
immunodeficiency virus (HIV) disease requiring antiviral treatment.

- Hepatitis A, B, or C active infection.

- Women of childbearing potential or male participant with women of childbearing
potential who do not agree to use highly effective method of birth control.

The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.

Eligibility last updated 6/27/22. 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

Jacksonville, Fla.

Mayo Clinic principal investigator

Sikander Ailawadhi, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available