Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT02812706
Eligibility Criteria:
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 \<=2.
Exclusion criteria:
* Participants treated with any anti-CD38 agent.
* Diagnosed or treated for another malignancy within 5 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low-risk prostate cancer after curative therapy.
* Prior anticancer therapy (chemotherapy, targeted agents, immunotherapy) within 21 days prior to the first drug infusion unless otherwise specified below:
* Alkylating agents (e.g., Melphalan) within 28 days prior to the first dose of study treatment.
* Steroids treatment (e.g., prednisone greater than (\>)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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02812706
Study Brief:
Protocol Section:
NCT02812706