A Study of Isatuximab Added to Standard CyBorD Induction and Lenalidomide Maintenance Treatments in ND-TEMM

NCT04786028 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: CMRG 008
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 7

Brief Summary

This is a phase II multi-center, open label, single arm study to evaluate the safety and efficacy of Isatuximab administered intravenously in combination with CyBorD induction treatment and Lenalidomide maintenance treatment in a 28-day long cycle in autologous stem cell transplant-eligible patients.

Conditions

Multiple Myeloma

Keywords

Hematologic Diseases; Neoplasms; Multiple Myeloma; Isatuximab; Cyclophosphamide; Dexamethasone; Bortezomib; Lenalidomide

Outcome Measures

Primary Outcomes (1)

• Response rate (VGPR or better) defined by IMWG criteria

  To determine the response rate (VGPR or better) defined by IMWG criteria at 100 days (+/- 7 days) after the autologous stem cell transplant (ASCT).

  100 days

Study Arms (1)

Isatuximab with CyBorD and Lenalidomide Maintenance

EXPERIMENTAL

This is a single arm study of Isatuximab administered intravenously in combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD), and Lenalidomide maintenance treatment

Other: Isatuximab

Interventions

Isatuximab OTHER

Brand name for interventional drug is Sarclisa

Isatuximab with CyBorD and Lenalidomide Maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, age 18 to 75 years of age.
• ECOG performance status score of 0, 1 or 2.
• Life expectancy of at least 9 months
• Measurable disease according to the IMWG criteria defined as
• Serum monoclonal paraprotein (M-protein) ≥ 10 g/L (if IgG) or ≥5g/L (if IgA, D, E or M)
• Urine M-protein ≥ 200 mg/24 h
• Serum free light chains (FLC) assay: Involved FLC level ≥ 100 mg/L and an abnormal serum free light chain ratio (\< 0.26 or \> 1 .65) if no M-protein detected in serum or urine
• Newly Diagnosed Symptomatic Multiple Myeloma by IMWG criteria
• The following laboratory results must be met within 10 days of first study drug administration:
• ANC ≥ 1.0 x 109/L
• Hemoglobin ≥ 80 g/L (transfusions permitted)
• Platelets ≥ 70 x 109/L (or ≥50 x 109/L if ≥50% plasmacytosis in bone marrow.
• Calculated CrCl ≥ 30 mL/min
• AST and ALT ≤ 3.0 x ULN
• Total bilirubin ≤ 2 x ULN unless known to have Gilbert's disease

You may not qualify if:

• Prior exposure to Isatuximab (or other anti-CD38 monoclonal antibody)
• Prior treatment for Multiple Myeloma (MM) with the exception of corticosteroids not exceeding a total dose specified below:
• Subjects who have received steroids within 2 weeks prior to starting study treatment or who have not recovered from side effects of such therapy. Concomitant therapy medications that include corticosteroids are allowed if subject receive ≤10 mg of prednisone per day, or equivalent, as indicated for other medical conditions, or up to 100 mg of hydrocortisone as pre-medication for administration of certain medications or blood products prior to enrolment in this study.
• Prior history of malignancies, other than MM, unless the subject has been free of the disease for 3 years or longer. Exceptions include the following:
• Basal or squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix or breast
• Adenocarcinoma of the prostate (TNM stage of T1 a or T1 b)
• Other concurrent severe and/or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection, acute diffuse pulmonary disease, pericardial disease, uncontrolled thyroid dysfunction or uncontrolled severe arterial hypertension) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
• History of or current uncontrolled cardiovascular disease including:
• Unstable angina, myocardial infarction, or known congestive heart failure Class III/IV (Appendix 5) within the preceding 12 months
• Transient ischemic attack within the preceding 3 months, pulmonary embolism within the preceding 2 months.
• Any of the following: sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, cardiac arrest, Mobitz II second degree heart block or third-degree heart block; known presence of dilated, hypertrophic, or restrictive cardiomyopathy.
• QTc prolongation as confirmed by ECG assessment at screening (QTc \>470 milliseconds).
• Poorly controlled severe arterial hypertension.
• Women who are pregnant, breastfeeding or planning to become pregnant while enrolled in this study, or within 90 days after the last dose of study medications. Male subject who plans to father a child while enrolled in this study, within 90 days after the last dose of study medications.

Sponsors & Collaborators

• Canadian Myeloma Research Group: lead

Study Sites (7)

Cross Cancer Institute

Edmonton, Alberta, T6G1Z2, Canada

Location

Nova Scotia Health - QEII Health Sciences Centre

Halifax, Nova Scotia, B3H1V7, Canada

Location

Hamilton Health Sciences Centre

Hamilton, Ontario, L8L2X2, Canada

Location

The Ottawa Hospital General Campus

Ottawa, Ontario, K1H8L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G2C1, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T7T1, Canada

Location

Saskatoon Cancer Center

Saskatoon, Saskatchewan, S7N4H4, Canada

Location

MeSH Terms

Conditions

Multiple Myeloma; Hematologic Diseases; Neoplasms

Interventions

isatuximab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: March 8, 2021
• Study Start: December 8, 2021
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)