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Multiple MyelomaPhase 1NCT03733717

Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma

A Phase 1 study testing Isatuximab SAR650984 in people with Multiple Myeloma, run by Sanofi at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: To evaluate the pharmacokinetics (PK) of isatuximab. Secondary Objectives: To evaluate the safety and tolerability of isatuximab. To assess the preliminary antitumor effect of isatuximab. To evaluate the immunogenicity of isatuximab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Isatuximab SAR650984
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
3 sitesChina
Study dates
22 Oct 2018to 25 Aug 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Known diagnosis of symptomatic multiple myeloma.
  • At least 2 prior lines of therapies which must include treatment with at least 1 of an immunomodulatory drug (IMiD) or a proteasome inhibitor (PI). The patients must have received an IMiD or a PI for ≥2 cycles or ≥2 months of treatment.
  • Patients must have been responsive to at least 1 prior line of therapy (minimal response or better).
  • Refractory to the most recently received IMiD or PI included therapy (ie, patients must have progressed during or within 60 days of completion of treatment with IMiD or PI). For patients who have received more than 1 type of IMiD or PI, their disease must be refractory to the most recent one.
  • Measurable disease defined as at least 1 of the following:
  • Serum M-protein ≥0.5 g/dL (≥5 g/L);
  • Urine M-protein ≥200 mg/24 hours.
  • Written informed consent.

Who cannot join

  • <18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status >2.
  • Life expectancy of less than 3 months.
  • Pretreated with any anticluster of differentiation (CD) 38 agent.
  • Concurrent plasma cell leukemia.
  • Known amyloidosis.
  • Disease measurable only by serum free light chain (FLC) analysis.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Investigational Site Number 1560003

    Beijing, 100191

  • Investigational Site Number 1560002

    Nanjing, 210029

  • Investigational Site Number 1560001

    Tianjin, 300020

Other trials in China

About this study

Official title: An Open-label, Multi-center Study to Evaluate the Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma

Primary Objective:

To evaluate the pharmacokinetics (PK) of isatuximab.

Secondary Objectives:

  • To evaluate the safety and tolerability of isatuximab.
  • To assess the preliminary antitumor effect of isatuximab.
  • To evaluate the immunogenicity of isatuximab.
Read the detailed description

The duration of the study for an individual patient will include a screening period of up to 21 days, a treatment period of repeated 28-day cycles, and a follow-up period. End of treatment visit will be done at 30 (±7) days after last treatment.

Being tested
Isatuximab SAR650984
Keywords
Anti-CD38 monoclonal antibody
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isatuximab SAR650984Drug

    Also called Sarclisa

    Pharmaceutical form: Concentrate for solution

    Route of administration: Intravenous

Study groups in NCT03733717
Study groupRoleWhat they receive
IsatuximabExperimentalAdministered intravenously every week in Cycle 1 (4 weeks) followed by every 2 weeks (Q2W) in subsequent cycles.
Receives: Drug: Isatuximab SAR650984

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of PK: Cmax

    To evaluate the maximum observed concentration (Cmax)

    Measured: Cycle 1, up to 168 hours after start of infusion

  2. Assessment of PK: tmax

    To evaluate the time to reach Cmax (tmax)

    Measured: Cycle 1, up to 168 hours after start of infusion

  3. Assessment of PK: AUC0-168h

    To evaluate area under the plasma concentration versus time curve over the dosing interval (AUC0-168h)

    Measured: Cycle 1, up to 168 hours after start of infusion

  4. Assessment of PK: Ceoi

    To evaluate the concentration observed at the end of an IV infusion (Ceoi)

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1; Cycle duration is 28 days

  5. Assessment of PK: Ctrough

    To evaluate concentration observed just before investigational medicinal product (IMP) administration during repeated dosing (Ctrough)

    Measured: Up to approximately 40 weeks (Cycle 10)

Secondary outcomes (7)

  1. Adverse Events

    Treatment Emergent Adverse Events (TEAEs)/Serious Adverse Events (SAE) based on standard and systematic assessment including infusion associated reactions (IARs), laboratory test abnormalities, vital signs and ECOG performance status

    Measured: Up to 30 days after the last IMP administration

  2. Anti-tumor activity: Overall response (ORR)

    Proportion of patients achieving: stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to International Myeloma Working Group (IMWG 2016) criteria

    Measured: Up to 12 months after last patient treated

  3. Anti-Tumor Activity: Duration of response (DOR)

    Time from the date of the first determined response to the date of subsequent determined progressive disease or death, whichever happens earlier

    Measured: Up to 12 months after last patient treated

  4. Anti-Tumor Activity: Time to progression (TTP)

    Time interval from the date of first IMP administration to the date of the first assessed disease progression using IMWG criteria

    Measured: Up to 12 months after last patient treated

  5. Anti-Tumor Activity: Progression free survival (PFS)

    Time interval from the date of first IMP administration to the date of the first documentation of disease progression or death due to any cause, whichever comes first

    Measured: Up to 12 months after last patient treated

  6. Anti-Tumor Activity: Overall survival (OS)

    Time interval from the date of first IMP administration to death due to any cause

    Measured: Up to 12 months after last patient treated

  7. Immunogenicity

    To evaluate the presence of antidrug antibodies (ADA) to isatuximab

    Measured: Up to 13 months (10 cycles + 3 months) after last patient treated

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start22 Oct 2018
  3. Primary completion6 Sep 2020
  4. Study completion25 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03733717
Sponsor's protocol ID
TED15085
Other IDs
U1111-1195-6028
Status last verified
Sep 2023
First submitted
31 Oct 2018
Last updated
8 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Sun M, Jing H, Qu X, Dong F, Li Y, Feng Z, Ziti-Ljajic S, Semiond D, Li L, Qi J, Qiu L. Phase 1 study of isatuximab monotherapy in Chinese patients with relapsed/refractory multiple myeloma. Sci Rep. 2024 Nov 11;14(1):27550. doi: 10.1038/s41598-024-59186-1.

    PubMed 39528489

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Isatuximab SAR650984 in people with Multiple Myeloma, run by Sanofi at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of PK: Cmax (time frame: Cycle 1, up to 168 hours after start of infusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03733717, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.

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