Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03194867) enrolled 109 participants across four treatment groups. A small Phase 1 group of 3 people received a combination of two drugs — isatuximab and cemiplimab — given once every two weeks, to check for any early warning signs of serious side effects. The larger Phase 2 part then compared three approaches in 106 people: isatuximab alone (34 participants), isatuximab plus cemiplimab every two weeks (35–36 participants), or isatuximab plus cemiplimab every four weeks (36 participants). The trial was measuring how often participants' disease responded to treatment, as well as tracking side effects and how long any response lasted. The reported data shows that in Phase 1, none of the 3 participants experienced what the trial defined as a "dose-limiting toxicity" — that is, a serious side effect severe enough to flag a problem with the dose. For side effects more broadly, the reported data shows that across all groups, most participants experienced at least one treatment-emergent adverse event (an unwanted medical occurrence after starting treatment): 3 of 3 in Phase 1, 33 of 34 in the isatuximab-alone group, 36 of 35–36 in the every-two-weeks combination group, and 33 of 36 in the every-four-weeks combination group. Serious adverse events were reported in 1 of 3 (Phase 1), 17 of 34, 17 of 35–36, and 21 of 36 participants respectively. The reported data shows that in Phase 2, the proportion of participants whose disease met the criteria for a measurable response was 11.8% in the isatuximab-alone group, 25.0% in the every-two-weeks combination group, and 22.2% in the every-four-weeks combination group. When a broader measure — including smaller, partial improvements — was used, those figures rose to 23.5%, 36.1%, and 38.9% respectively. Among participants who did show a response, the median length of time that response lasted was reported as 5.6 months, 4.7 months, and 5.7 months across the three groups. Participants were followed up for a median of approximately 8.8 to 10.3 months depending on the group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Myeloma Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with multiple myeloma and the disease can be measured through specific blood, urine, or protein tests.
- You have previously been treated with two specific types of myeloma drugs — an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI) — each for at least 2 cycles or 2 months.
- You have already been through at least 3 separate rounds (lines) of treatment for your myeloma (note: initial treatment plus a stem cell transplant and any maintenance counts as just one line).
- At some point, your myeloma has shown at least a minimal response to a myeloma treatment — meaning your disease has never been completely unresponsive to all treatments tried so far.
Who may not be able to join:
- You have previously been treated with the drug isatuximab, or have taken part in a clinical study involving isatuximab.
- You have previously taken any drug (approved or experimental) that targets a pathway in the immune system known as PD-1/PD-L1.
- You have another condition affecting your immune system (confirm with trial site).
- You have had a lung inflammation condition (not caused by infection) that needed steroid treatment, currently have lung inflammation, or have had radiation treatment to your chest area.
- You have received a live-virus vaccine within the 30 days before starting treatment (standard flu vaccines without live virus are generally acceptable).
- You have had a stem cell transplant using cells donated by another person (an allogeneic transplant).
- You have previously been treated with a drug called idelalisib.
- Your general health and ability to carry out daily activities is significantly limited (confirm with trial site).
- Your bone marrow is not functioning well enough (confirm with trial site).
- Your major organs (such as kidneys, liver, or heart) are not functioning well enough (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Clinical Sciences & Operations, Sanofi
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs); Phase 1 and Phase 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs); Phase 2: Percentage of Participants With Overall Response Rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.