50 Participants Needed

Isatuximab + Lenalidomide for Multiple Myeloma

(HEME-18 Trial)

PP
KS
Overseen ByKaren Sweiss, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Illinois at Chicago
Must be taking: Lenalidomide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This is a phase II study where patients will undergo isatuximab and lenalidomide maintenance if they are MRD-positive after Autologous Stem Cell Transplant (ASCT)

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be willing to take certain blood thinners (like aspirin or warfarin) while receiving lenalidomide.

What data supports the effectiveness of the drug combination Isatuximab and Lenalidomide for treating multiple myeloma?

Research shows that Isatuximab, when combined with other drugs like lenalidomide, can improve the response and delay the progression of multiple myeloma in patients who have tried other treatments. In studies, this combination was generally well tolerated and showed promising results in patients with relapsed or hard-to-treat multiple myeloma.12345

Is the combination of Isatuximab and Lenalidomide safe for treating multiple myeloma?

The combination of Isatuximab and Lenalidomide has been generally well tolerated in clinical trials for multiple myeloma, with manageable side effects. Common side effects include infusion-related reactions, infections, and blood-related issues like low white blood cell counts, but these were mostly mild to moderate in severity.23678

How is the drug Isatuximab + Lenalidomide unique for treating multiple myeloma?

Isatuximab combined with lenalidomide and dexamethasone is unique because it targets the CD38 protein on myeloma cells, enhancing the immune system's ability to fight the cancer. This combination has shown effectiveness in patients who have already tried other treatments, offering a new option for those with relapsed or refractory multiple myeloma.23679

Eligibility Criteria

Adults over 18 with confirmed multiple myeloma, who've had less than two prior therapies and are planning or have recently completed an Autologous Stem Cell Transplant (ASCT). They must be MRD-positive post-ASCT, able to take oral meds, agree to contraception use, and not have certain health conditions that could interfere with the trial.

Inclusion Criteria

Willingness to abstain from heterosexual activity or to use 2 forms of effective contraception from the time of informed consent until 5 months for females, and 1 month for males after treatment discontinuation
I've been mostly active and able to care for myself in the last 30 days.
I am older than 18 years.
See 9 more

Exclusion Criteria

Treatment with any investigational drug within 30 days prior to enrollment
My multiple myeloma has spread to my brain or spinal cord.
I have hepatitis C with a known viral load.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive isatuximab and lenalidomide maintenance therapy if MRD-positive after ASCT

3 years
Isatuximab IV Days 1, 8, 15, 22 Cycle 1; Days 1, 15 Cycles 2-3; Day 1 Cycles 4-39. Lenalidomide PO Days 1-21 Cycles 1-3; Days 1-21 Cycle 4 onwards

Follow-up

Participants are monitored for disease response and MRD status every 12 months

3 years

Treatment Details

Interventions

  • Isatuximab
  • Lenalidomide
Trial OverviewThe study is testing maintenance therapy using Isatuximab and Lenalidomide in patients who still show minimal residual disease after ASCT. It's a phase II trial aiming to see how effective this combination is for keeping the cancer at bay.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Isatuximab and Lenalidomide MaintenanceExperimental Treatment2 Interventions
All participants will receive: Isatuximab 10mg/kg IV Days 1,8, 15, 22 Cycle 1 (all cycles 28 days). Isatuximab 10mg/kg Days 1, 15 Cylces 2 and 3. Isatuximab 10mg/kg Day 1, Cylces 4-39. Lenalidomide 10mg PO Days 1-21 Cylces 1-3 (all cycles 28 days) Lenalidomide 15mg PO Days 1-21 Cycle 4 and can continue until disease progression.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Huntsman Cancer Institute

Collaborator

Trials
14
Recruited
7,700+

Findings from Research

In a phase 3 trial involving 660 patients with newly diagnosed multiple myeloma, the addition of isatuximab to standard treatment (lenalidomide, bortezomib, and dexamethasone) significantly improved the rate of minimal residual disease (MRD) negativity, with 50% of patients in the isatuximab group achieving MRD negativity compared to 36% in the control group.
The safety profile of isatuximab was consistent with existing treatments, showing no new safety concerns, although higher rates of grade 3 or 4 neutropenia were observed in the isatuximab group (23% vs. 7% in the control group).
Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial.Goldschmidt, H., Mai, EK., Bertsch, U., et al.[2022]
Isatuximab, an anti-CD38 monoclonal antibody, significantly improves progression-free survival and tumor response when combined with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma, based on phase III studies.
The combination therapies involving isatuximab were generally well tolerated, maintaining health-related quality of life and showing a manageable safety profile without new safety concerns.
Isatuximab: A Review of Its Use in Multiple Myeloma.Frampton, JE.[2022]
In a phase 1b study involving 57 patients with relapsed/refractory multiple myeloma, the combination of isatuximab, lenalidomide, and dexamethasone was found to be generally well tolerated, with only one dose-limiting toxicity reported, indicating a favorable safety profile.
The treatment demonstrated an overall response rate of 56% and a median progression-free survival of 8.5 months, suggesting that isatuximab is an effective option for patients who have previously undergone multiple treatments.
A phase 1b study of isatuximab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma.Martin, T., Baz, R., Benson, DM., et al.[2021]

References

Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial. [2022]
Isatuximab: A Review of Its Use in Multiple Myeloma. [2022]
A phase 1b study of isatuximab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma. [2021]
Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis. [2022]
An evaluation of isatuximab, pomalidomide and dexamethasone for adult patients with relapsed and refractory multiple myeloma. [2022]
Efficacy of isatuximab in combination with steroids for the treatment of relapsed/refractory multiple myeloma patients exhibiting only biochemical progression-A single center retrospective study. [2023]
EMA Review of Isatuximab in Combination with Pomalidomide and Dexamethasone for the Treatment of Adult Patients with Relapsed and Refractory Multiple Myeloma. [2021]
Isatuximab: First Approval. [2021]
Matching-adjusted indirect comparison of isatuximab plus carfilzomib and dexamethasone with daratumumab plus lenalidomide and dexamethasone in relapsed multiple myeloma. [2023]