Can a shot replace an IV for myeloma treatment?
NCT ID NCT04045795
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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56 people
The number who actually took part.
- Started
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Aug 2019
- Finished
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Mar 2024
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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City of Hope Site Number : 8400002
Duarte, California, 91010, United States
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Gabrail Cancer Center Site Number : 8400001
Canton, Ohio, 44718, United States
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Investigational Site Number : 0360001
Wollongong, New South Wales, 2500, Australia
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Investigational Site Number : 0360002
Blacktown, New South Wales, 2148, Australia
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Investigational Site Number : 0360003
Richmond, Victoria, 3121, Australia
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Investigational Site Number : 0360004
Fitzroy, Victoria, 3065, Australia
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Investigational Site Number : 0560001
Leuven, 3000, Belgium
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Investigational Site Number : 2500001
Nantes, 44093, France
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Investigational Site Number : 2500002
Toulouse, 31059, France
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Investigational Site Number : 3920001
Shibuya-ku, Tokyo, 150-8935, Japan
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Investigational Site Number : 3920002
Okayama, Okayama-ken, 701-1192, Japan
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Investigational Site Number : 7240001
Badalona, Catalunya [Cataluña], 08916, Spain
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Investigational Site Number : 7240002
Santander, Cantabria, 39008, Spain
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~Banner MD Anderson Cancer Center Site Number : 8400005
Gilbert, Arizona, 85234, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a stronger drug cocktail give older myeloma patients a better start?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas