All studies
Active not recruitingPHASE3INTERVENTIONAL

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

This study is for people with a type of blood cancer called multiple myeloma that has come back. It's comparing two ways of giving a medicine called isatuximab: as an injection under the skin (subcutaneous, or SC) or through a drip into a vein (intravenous, or IV). Both methods are given along with two other standard treatments, pomalidomide and dexamethasone. The aim is to see if the under-the-skin injection is as effective and safe as the IV drip. Patients will be randomly assigned to one of the two treatment groups and continue treatment as long as it's helping and well-tolerated, or until the disease gets worse.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Sanofi
Enrolment target
531
Start
23 Jun 2022
Estimated completion
23 Mar 2027

Results

Results from this study

Posted November 2025

Results have been published for this study.

Primary outcome
Overall Response Rate (ORR)
ORR by independent review committee (IRC) using 2016 international myeloma working group (IMWG) criteria:Percentage of participants with complete response (CR),stringent CR (sCR),very good partial response (VGPR) \& partial response (PR).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas (STP),\<5% plasma cells in bone marrow (BM) aspirates \& a normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy. VGPR:serum \& urine M-protein detectable by immunofixation, not electrophoresis;\>=90% reduction in serum M-protein plus urine M-protein level\<100mg/24hour(h);\>=90% decrease in sum of maximal perpendicular diameter (SPD) compared to baseline in STP;FLC only:\>=90% decrease in difference between involved and uninvolved FLC levels.PR:\>=50% reduction of serum M-protein and reduction in 24h urine M-protein by \>=90% or to \<200mg/24h.In addition to above, if present at baseline,\>=50% reduction in size SPD of STPs also required.
Full results on the registry

What is this study about?

This study is trying to find the best way to give a medicine called Isatuximab to people with a type of blood cancer called multiple myeloma. This is for people whose multiple myeloma has returned even after they've had other treatments, including a medicine called lenalidomide and a proteasome inhibitor.

Currently, Isatuximab is given through a drip into a vein. This study wants to see if giving it as a simple injection under the skin is just as good. Both ways of giving Isatuximab would be combined with two other common multiple myeloma medicines, Pomalidomide and Dexamethasone. By looking at these two different ways of giving Isatuximab, doctors hope to find a more convenient option for patients.

This kind of study is called a Phase 3 trial, which means it’s a big study involving many people, designed to confirm if a new treatment or a new way of giving a treatment is safe and effective when compared to existing methods. Everyone in the study will continue their treatment for as long as it's working and they are feeling well, or until their doctor decides it's no longer the best option.

Key takeaways

  • Compares two ways of giving Isatuximab for multiple myeloma.
  • Investigates an under-the-skin injection vs. an IV drip.
  • Always combined with Pomalidomide and Dexamethasone.
  • For adults with multiple myeloma that has returned.
  • Treatment continues as long as it's working.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have multiple myeloma that has come back, especially if they've already received certain other treatments including lenalidomide and a proteasome inhibitor. Your doctors will also need to be able to measure your multiple myeloma in your blood or urine to track how the treatment is working.

There are also reasons someone might not be able to join. For example, if your multiple myeloma is growing very rapidly from the start (primary refractory), or if you've already had a similar medicine to Isatuximab too recently or had a bad reaction to it. You also wouldn't be able to join if you've previously taken pomalidomide, which is one of the treatments given in this study. Other health conditions like serious heart problems, certain previous cancers, or active infections like Hepatitis, would also prevent you from joining.

Women who could become pregnant and men with partners who could become pregnant would need to agree to use effective birth control throughout the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you an adult aged 18 or over?
  2. Do you have multiple myeloma that has returned?
  3. Have you had at least one prior treatment for multiple myeloma, including lenalidomide and a proteasome inhibitor?
  4. Can your multiple myeloma be measured in your blood or urine?
  5. Have you NOT had a medicine similar to Isatuximab in the last 9 months or had a bad reaction to it?
  6. Have you NOT taken Pomalidomide before?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups: one receiving Isatuximab as an injection under the skin, and the other receiving it through a drip into a vein. Regardless of the group, you'll also receive Pomalidomide and Dexamethasone. You will continue these treatments in cycles, typically lasting 4 weeks each. You'll have regular hospital visits for your treatments, check-ups, and blood tests to see how you're doing and how the treatment is affecting your body. You'll continue treatment for as long as it is working for you and you're not having difficult side effects, or until your doctor advises otherwise. You’ll be taking some preventative medicines like Montelukast, Paracetamol, Diphenhydramine, and Methylprednisolone to help manage potential reactions to the study drug.

Potential risks and benefits

Taking part in this study could offer you access to a different way of receiving Isatuximab, potentially a more convenient under-the-skin injection. However, there are potential risks, as all medicines can have side effects. These will be carefully monitored by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (146)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Mohtaseb Cancer Center and Blood Disorders Site Number : 8400028
    Verified postcode
    Bullhead City, United States
  • Arizona Oncology Associates, PC - HAL- Site Number : 8400015
    Verified postcode
    Prescott Valley, United States
  • Rocky Mountain Cancer Centers, LLP- Site Number : 8400021
    Verified postcode
    Aurora, United States
  • Mayo Clinic- Site Number : 8400008
    Verified postcode
    Jacksonville, United States
  • BRCR Medical Center Inc Site Number : 8400030
    Verified postcode
    Plantation, United States
  • Centre for Cancer and Blood Disorders- Site Number : 8400026
    Verified postcode
    Bethesda, United States
  • Hattiesburg Clinic Site Number : 8400006
    Verified postcode
    Hattiesburg, United States
  • Comprehensive Cancer Centers of Nevada- Site Number : 8400019
    Verified postcode
    Las Vegas, United States
  • Atlantic Health System Site Number : 8400005
    Verified postcode
    Morristown, United States
  • New York Oncology Hematology, P.C.- Site Number : 8400017
    Verified postcode
    Albany, United States
  • Novant Health- Site Number : 8400014
    Verified postcode
    Charlotte, United States
  • Novant Health Forsyth Medical Center Site Number : 8400114
    Verified postcode
    Winston-Salem, United States

Common questions

What is the main goal of this study?

The main goal is to see if giving Isatuximab as an injection under the skin is as safe and effective as giving it through a drip into a vein, both alongside other standard treatments for multiple myeloma.

Who can join this study?

Adults with multiple myeloma that has come back after at least one previous treatment, including lenalidomide and a proteasome inhibitor.

What treatments will I receive?

You'll receive Isatuximab (either as an injection or a drip), Pomalidomide, and Dexamethasone. You'll also get some other medicines to help prevent reactions.

How long will I be on the treatment?

You'll continue treatment in 4-week cycles for as long as it's helping and you're tolerating it well, or until your disease progresses or you wish to stop.

Can I leave the study if I want to?

Yes, you can leave the study at any time for any reason, and it won't affect your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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