Multi-center Open-label Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

STATUS

Recruiting
participants needed

46
sponsor

Sanofi

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Updated on 19 February 2024

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antibiotic

dexamethasone

corticosteroids

antibiotics

antibiotic therapy

measurable disease

multiple myeloma

lenalidomide

hepatitis b surface antigen

arginine

premedication

hepatitis

tuberculosis

hepatitis a

refractory multiple myeloma

isatuximab

hbv dna

contraceptive use

pomalidomide

hepatitis c

proteasome inhibitor

parenteral administration

hydrochloride salt

arginine hydrochloride

Summary

Primary Objectives:

To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV)
To evaluate the pharmacokinetics (PK) of SC and IV isatuximab

Secondary Objectives:

To estimate absolute bioavailability of SC and IV isatuximab
To measure receptor occupancy (RO) after isatuximab SC versus IV administration
To assess efficacy of isatuximab after SC and IV administration
To assess patient expectations prior to and patient experience and satisfaction after SC administration
To evaluate potential immunogenicity of SC or IV isatuximab

Description

Total study duration is variable depending on treatment and follow-up periods, including 21 days of screening, and treatment period until disease progression, unacceptable adverse reaction or other reason for discontinuation. End of treatment will be 30 days after last administration of investigational medicinal product, or approximately 14 months after first study treatment administration.

Details

Condition	Multiple Myeloma, Multiple Myeloma, Lymphoproliferative Disorder, lymphoproliferative disorders, lymphoproliferative disorders
Age	18years - 100years
Treatment	Dexamethasone, Isatuximab SAR650984, Pomalidomide
Clinical Study Identifier	NCT04045795
Sponsor	Sanofi
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
	Participant must be above 18 years of age or country's legal age of majority if the legal age is >18 years old, at the time of signing the informed consent
	Participant has been previously diagnosed with multiple myeloma (MM) based on standard criteria and currently requires treatment because MM has relapsed following a response, according to International Myeloma Working Group (IMWG) criteria
	Participant has received at least two previous therapies including lenalidomide and a proteasome inhibitor and has demonstrated disease progression on last therapy or after completion of the last therapy
	Participants with measurable disease defined as at least one of the following
	Serum M protein 0.5 g/dL (5 g/L)
	Urine M protein 200 mg/24 hours
	Serum free light chain (FLC) assay: Involved FLC assay 10 mg/dL ( 100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
	Male or female: Contraceptive use by men or women
Exclusion Criteria
	Malignancy within 3 years prior to enrollment
	Eastern Cooperative Oncology Group (ECOG) performance status score >2\
	Inadequate hematological, liver or renal function
	Serum calcium (corrected for albumin) level above the upper limit of normal (ULN) range
	Patients with prior anti-CD38 treatment are excluded if
	Refractory to anti-CD38 treatment defined as progression on or within 60 days of the last dose of the anti-CD38 or
	Intolerant to the anti-CD38 previously received or
	Progression after initial response on anti-CD38 therapy with a washout period inferior to 9 months before the first dose of isatuximab SC or IV
	Participant did not achieve a minimal response or better to at least one of the previous lines of treatment (ie, primary refractory disease is not eligible)
	Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer
	Prior anti-cancer therapy within 14 days
	Any >Grade 1 adverse reaction unresolved from previous treatments according to the NCI-CTCAE v5.0. The presence of alopecia or peripheral neuropathy Grade 2 without pain is allowed
	Previous allogeneic stem cell transplantation with active Graft Versus Host Disease or being under immunosuppressive therapy in the last 2 months previously to the inclusion in the trial
	Daily requirement for corticosteroids
	Known to be HIV+ or to have hepatitis A or uncontrolled or active hepatitis B virus (HBV) infection (patients with positive HBsAg [HBsAg] and/or HBV DNA) or active HCV (HCV) infection (positive HCV RNA and negative anti-HCV)
	Active tuberculosis and severe infections requiring treatment with antibiotic parenteral administration
	Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the patient or may interfere with compliance or interpretation of the study results
	History of erythema multiforme or severe hypersensitivity to prior immunomodulatory drugs (IMiDs)
	Hypersensitivity or history of intolerance to immunomodulatory drugs (IMiDs), dexamethasone, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study therapy that are not amenable to premedication with steroids and histamine H2 blockers or would prohibit further treatment with these agents
	Inability to tolerate thromboprophylaxis
	The above information is not intended to contain all considerations relevant
	to a patient's potential participation in a clinical trial

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Study Definition

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Multi-center Open-label Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)