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Can a shot replace an IV for myeloma treatment?

NCT ID NCT04045795

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a drug combination (isatuximab, pomalidomide, and dexamethasone) in 56 patients with multiple myeloma that had returned or stopped responding to prior treatments. The main goal was to see if giving isatuximab as a shot under the skin works as well as giving it through an IV, and to check safety and side effects. Researchers also looked at how well the treatment controlled the cancer and how patients felt about the shot method.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isatuximab (Sarclisa) plus pomalidomide and dexamethasone
What this could lead to
If successful, this could offer a new treatment option for patients with multiple myeloma that has returned or stopped responding to other therapies.
What could go wrong
This is an early-phase trial with only 56 participants, so results may not apply to all patients. Side effects from the drug combination are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

56 people

The number who actually took part.

Started

Aug 2019

Finished

Mar 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. * Participant must be above 18 years of age or country's legal age of majority if the legal age is \>18 years old, at the time of signing the informed consent. * Participant has been previously diagnosed with multiple myeloma (MM) based on standard criteria and currently requires treatment because MM has relapsed following a response, according to International Myeloma Working Group (IMWG) criteria. * Participant has received at least two previous therapies including lenalidomide and a proteasome inhibitor and has demonstrated disease progression on last therapy or after completion of the last therapy. * Participants with measurable disease defined as at least one of the following: * Serum M protein ≥ 0.5 g/dL (≥5 g/L). * Urine M protein ≥ 200 mg/24 hours. * Serum free light chain (FLC) assay: Involved FLC assay ≥ 10 mg/dL (≥ 100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65). * Male or female: Contraceptive use by men or women Exclusion criteria: * Malignancy within 3 years prior to enrollment. * Eastern Cooperative Oncology Group (ECOG) performance status score \>2. * Inadequate hematological, liver or renal function. * Serum calcium (corrected for albumin) level above the upper limit of normal (ULN) range. * Patients with prior anti-CD38 treatment are excluded if: * Refractory to anti-CD38 treatment defined as progression on or within 60 days of the last dose of the anti-CD38 or, * Intolerant to the anti-CD38 previously received or, * Progression after initial response on anti-CD38 therapy with a washout period inferior to 9 months before the first dose of isatuximab SC or IV. * Participant did not achieve a minimal response or better to at least one of the previous lines of treatment (ie, primary refractory disease is not eligible). * Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer. * Prior anti-cancer therapy within 14 days. * Any \>Grade 1 adverse reaction unresolved from previous treatments according to the NCI-CTCAE v5.0. The presence of alopecia or peripheral neuropathy ≤ Grade 2 without pain is allowed. * Previous allogeneic stem cell transplantation with active Graft Versus Host Disease or being under immunosuppressive therapy in the last 2 months previously to the inclusion in the trial. * Daily requirement for corticosteroids. * Known to be HIV+ or to have hepatitis A or uncontrolled or active hepatitis B virus (HBV) infection (patients with positive HBsAg \[HBsAg\] and/or HBV DNA) or active HCV (HCV) infection (positive HCV RNA and negative anti-HCV). * Active tuberculosis and severe infections requiring treatment with antibiotic parenteral administration. * Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the patient or may interfere with compliance or interpretation of the study results. * History of erythema multiforme or severe hypersensitivity to prior immunomodulatory drugs (IMiDs). * Hypersensitivity or history of intolerance to immunomodulatory drugs (IMiDs), dexamethasone, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study therapy that are not amenable to premedication with steroids and histamine H2 blockers or would prohibit further treatment with these agents. * Inability to tolerate thromboprophylaxis. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • City of Hope Site Number : 8400002

    Duarte, California, 91010, United States

  • Gabrail Cancer Center Site Number : 8400001

    Canton, Ohio, 44718, United States

  • Investigational Site Number : 0360001

    Wollongong, New South Wales, 2500, Australia

  • Investigational Site Number : 0360002

    Blacktown, New South Wales, 2148, Australia

  • Investigational Site Number : 0360003

    Richmond, Victoria, 3121, Australia

  • Investigational Site Number : 0360004

    Fitzroy, Victoria, 3065, Australia

  • Investigational Site Number : 0560001

    Leuven, 3000, Belgium

  • Investigational Site Number : 2500001

    Nantes, 44093, France

  • Investigational Site Number : 2500002

    Toulouse, 31059, France

  • Investigational Site Number : 3920001

    Shibuya-ku, Tokyo, 150-8935, Japan

  • Investigational Site Number : 3920002

    Okayama, Okayama-ken, 701-1192, Japan

  • Investigational Site Number : 7240001

    Badalona, Catalunya [Cataluña], 08916, Spain

  • Investigational Site Number : 7240002

    Santander, Cantabria, 39008, Spain

  • ~Banner MD Anderson Cancer Center Site Number : 8400005

    Gilbert, Arizona, 85234, United States

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