Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients

Inclusion criteria

• Males or females, age 20 years or older.
• Participants had a known diagnosis of symptomatic multiple myeloma.
• Participants had received at least 3 prior lines of therapies OR participants whose disease was double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI).
• Participants had been responsive (i.e., minimal response [MR] or better) to at least one prior line of therapy.
• Refractory to the most recently received IMiD or PI included therapy.
• Participants with measurable disease defined as at least one of the following:
• Immunoglobulin G (IgG) Type: Serum M-protein >=1 gram per deciliter (g/dL) (>=10 g/L);
• Immunoglobulin A (IgA) and D Type: Serum M-protein, quantification should be performed;
• Urine M-protein ≥200 mg/24 hours.
• Participants with a Eastern Cooperative Oncology Group (ECOG) performance status )10 mg/day orally or equivalent except patients being treated for adrenal insufficiency/replacement therapy or treated for inhalation corticosteroids) within 14 days prior to the first dose of study treatment.
• Participated in another clinical trial within 30 days prior to the first dose of study treatment.
• Participants treated with systemic radiation therapy within 4 weeks prior to the first dose of study treatment OR Localized radiation therapy within 1 week prior to the first dose of study treatment.
• Major surgical procedure within 4 weeks prior to the first dose of study treatment.
• Any toxicity Grade >=2 (excluding alopecia, neutropenia or neuropathy) related to any prior anti-cancer therapy according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
• Neuropathy Grade >=3 or painful peripheral neuropathy Grade >=2.
• History of significant cardiovascular disease unless the disease within the past 6 months was well-controlled.
• Previously received an allogenic stem cell transplant.
• Diagnosed Crow-Fukase (POEMS) syndrome OR plasma cell leukemia.
• Participants with known or suspected amyloidosis.
• Participants with Waldenstrom's macroglobulinemia OR Multiple myeloma IgM subtype.
• Participants with active infection.
• Known human immunodeficiency virus (HIV) or active hepatitis B or C viral infection.
• Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation.
• Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results.
• Hypersensitivity or history of intolerance to boron or mannitol, sucrose, histidine (as base and hydrochloride salt) and polysorbate 80 or any of the components of study therapy that are not amenable to pre-medication with steroids and H2 blockers or would prohibit further treatment with these agents.

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