Back to results

Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma

Primary Purpose

Relapsed Multiple Myeloma, Refractory Multiple Myeloma

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Rapid Infusion Isatuximab

About this trial

This is an interventional treatment trial for Relapsed Multiple Myeloma focused on measuring Isatuximab Infusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed diagnosis of multiple myeloma (International Classification of Disease (ICD-10) code: C90.0)
Previous exposure to at least one proteasome inhibitors (PI) and lenalidomide (or candidacy for isatuximab as per updated Food and Drug Administration (FDA) package insert information in the future)
Planned or current isatuximab-containing therapy. Patients receiving isatuximab as part of a clinical trial are eligible for this study if allowed by the trial sponsor.
- For ease of registration, patients will be allowed to enroll at any point after the decision is made to initiate isatuximab (with the understanding that their initial doses will be standard of care (SOC), including the first 2 doses for all patients). However, rapid infusion (RI) isatuximab will only be administered to participants who have not had infusion-related reactions (iRRs) during >= 2 consecutive prior doses of SOC isatuximab
Ability to understand a written informed consent form (ICF) document, and the willingness to sign the ICF document

Exclusion Criteria:

Age < 18
Body weight > 70 kilograms (kg) at the time of any RI isatuximab dose
Current pregnancy or (if of reproductive age) unwillingness to follow contraception requirements as per the FDA package insert
New York Heart Association Stage IV heart disease, i.e. unable to carry on any physical activity without discomfort or symptoms of heart failure (as per study investigator)
Any medical condition, including mental illness or substance abuse, deemed by the principal investigator to interfere with the ability to provide consent or cooperate with study procedures

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (isatuximab)

Arm Description

Participants receive their first rapid infusion of isatuximab IV over 30 minutes. If a >=Grade 2 iRR occurs, then participants will revert to a SOC infusion time and be removed from the study. If a Grade 1 or no IRR occurs, then participants will receive another rapid infusion of 30 minutes. Participants will continue to receive RI and IRR assessment after each dose up to at least 6 doses or until a grade 2 or higher IRR occurs.

Outcomes

Primary Outcome Measures

Number of participants with reported grade 2 or higher infusion-related reactions (IRR)

The per-patient incidence of Grade 2 or higher IRRs with rapid infusion (RI) isatuximab will be calculated as the number of patients who developed >= 1 Grade 2+ IRR with RI isatuximab divided by the total number of patients who receive >= 1 dose of RI isatuximab.

Secondary Outcome Measures

Mean per-participant infusion duration

Descriptive statistics for total infusion durations in minutes including mean, standard deviation, and 95% confidence interval will be reported across the first 6 doses of RI isatuximab.

Full Information

NCT ID

NCT04802031

First Posted

March 13, 2021

Last Updated

July 3, 2022

Sponsor

Thomas Martin, MD

1. Study Identification

Unique Protocol Identification Number

NCT04802031

Brief Title

Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma

Official Title

Safety of Rapid-Infusion Isatuximab in Patients With Relapsed/Refractory Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Low accrual

Study Start Date

May 28, 2021 (Actual)

Primary Completion Date

November 30, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Thomas Martin, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This phase II trial studies the effects of isatuximab given as a rapid-infusion in treating multiple myeloma that has come back (recurrent) or has not responded to treatment (refractory). Isatuximab, also known as Sarclisa, is an antibody (proteins that can protect the body from foreign organisms, such as bacteria and viruses) directed against cluster of differentiation 38 (CD38), a receptor antigen (a receptor or protein on the outside of blood cells that can be used as a target). Isatuximab may stop the growth of some blood cancers. Normally, the fastest that intravenous isatuximab can be given - for patients who have not had any reactions to their first two doses - is over 1 hour and 15 minutes. This study is designed to test whether intravenous isatuximab can be given over 30 minutes ("rapid infusion") among patients who have not developed any reactions to at least 2 prior doses of intravenous isatuximab at normal speeds. If shown to be safe, "rapid infusion" isatuximab may ultimately improve the patient experience while reducing the overall cost of the infusion.

Detailed Description

PRIMARY OBJECTIVE: I. To evaluate the incidence of grade 2 or higher (Gr2+) infusion-related reactions (IRRs) with rapid-infusion (RI) isatuximab across 6 doses. SECONDARY OBJECTIVE: I. To estimate time savings with RI isatuximab (versus estimated standard of care [SOC] isatuximab duration lengths) across 6 doses of isatuximab. OUTLINE: Patients must have received standard of care isatuximab IV over for at least 2 doses without any Gr2+ IRRs reported. Patients will then receive a rapid infusion of isatuximab IV over 30 minutes. If a >=Grade 2 iRR occurs, then participants will revert to a SOC infusion time and be taken off the study. If a Grade 1 or no IRR occurs, then participants will receive another rapid infusion of 30 minutes and assessed again for IRRs. Rapid infusions and IRR assessment after each RI will continue for up to at least 6 doses or until the patient experiences an Grade 2 or higher IRR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed Multiple Myeloma, Refractory Multiple Myeloma

Keywords

Isatuximab Infusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (isatuximab)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Rapid Infusion Isatuximab

Other Intervention Name(s)

Hu 38SB19, ISATUXIMAB, Isatuximab-irfc, SAR 650984, SAR650984, Sarclisa

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

Number of participants with reported grade 2 or higher infusion-related reactions (IRR)

Description

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

Mean per-participant infusion duration

Description

Descriptive statistics for total infusion durations in minutes including mean, standard deviation, and 95% confidence interval will be reported across the first 6 doses of RI isatuximab.

Time Frame

9-12 weeks depending on isatuximab dosing interval

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed diagnosis of multiple myeloma (International Classification of Disease (ICD-10) code: C90.0) Previous exposure to at least one proteasome inhibitors (PI) and lenalidomide (or candidacy for isatuximab as per updated Food and Drug Administration (FDA) package insert information in the future) Planned or current isatuximab-containing therapy. Patients receiving isatuximab as part of a clinical trial are eligible for this study if allowed by the trial sponsor. For ease of registration, patients will be allowed to enroll at any point after the decision is made to initiate isatuximab (with the understanding that their initial doses will be standard of care (SOC), including the first 2 doses for all patients). However, rapid infusion (RI) isatuximab will only be administered to participants who have not had infusion-related reactions (iRRs) during >= 2 consecutive prior doses of SOC isatuximab Ability to understand a written informed consent form (ICF) document, and the willingness to sign the ICF document Exclusion Criteria: Age < 18 Body weight > 70 kilograms (kg) at the time of any RI isatuximab dose Current pregnancy or (if of reproductive age) unwillingness to follow contraception requirements as per the FDA package insert New York Heart Association Stage IV heart disease, i.e. unable to carry on any physical activity without discomfort or symptoms of heart failure (as per study investigator) Any medical condition, including mental illness or substance abuse, deemed by the principal investigator to interfere with the ability to provide consent or cooperate with study procedures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Martin, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Rapid-infusion Isatuximab in Relapsed/Refractory Multiple Myeloma

We'll reach out to this number within 24 hrs