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Isatuximab, Dexamethasone, and Lenalidomide for Ultra-Frail Multiple Myeloma

This study is looking at a new way to treat multiple myeloma (a cancer of plasma cells in the bone marrow) in patients who are very frail. It uses a "go-slow" approach with three medications: Isatuximab, Dexamethasone, and Lenalidomide. The study starts with Isatuximab and Dexamethasone, then slowly adds Lenalidomide in the third cycle. The goal is to see if this gentle approach helps patients stick with their treatment and improves their quality of life. You may be able to join if you are 18 or older, have newly diagnosed multiple myeloma or plasma cell leukemia, and have had no more than one previous treatment cycle. The study will measure how many patients complete 9 cycles of treatment.

Study design
This interventional study plans to enroll 40 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive Isatuximab weekly for the first two cycles, then every two weeks. Dexamethasone is given on the same days as Isatuximab and may be stopped after two cycles or continued. Lenalidomide is introduced from the third cycle onwards.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at the end of 9 cycles of treatment, with each cycle lasting 28 days.

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NCT06517017

Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Utah
~40 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:Isatuximab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Completion rate of 9 cycles of treatment
Measured over At the end of 9 cycles of treatment (each cycle is 28 days)

Conditions

Multiple Myeloma
Plasma Cell Leukemia

Explore related trials

Multiple MyelomaPlasma Cell Leukemia

Where it's being run

1 sites across 1 states
Utah1

Study leadership

  • Ghulam Rehman Mohyuddin, MBBS · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute

Who to contact

Rachel Kingsford
[email protected]
801-585-0115
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female subject aged ≥ 18 years.
Histologically confirmed myeloma and/or Plasma Cell Leukemia who are newly diagnosed and having completed ≤ 1 prior cycle of myeloma treatment.
For female subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization (bilateral oophorectomy or hysterectomy). The post-menopausal status will be defined as having been amenorrheic for 24 months without an alternative medical cause.
Subjects must be willing to follow contraception requirements listed in the protocol, agree to participate in the Lenalidomide REMS program, and have signed the Patient-Physician Agreement Form.
Male subjects must agree to use a latex condom during intercourse for the duration of study therapy as described in the protocol, even if he has undergone a successful vasectomy.
Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy per the treating investigator.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
IMWG defined frailty score ≥ 3. IMWG definition available here: http://www.myelomafrailtyscorecalculator.net

Exclusion

Receiving other investigational agents.
Any condition that would, in the Investigator's judgment, compromise the subject's ability to understand the subject information, give informed consent, and/or contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, \[subjects may not receive the drug through a feeding tube\], social/ psychological issues, etc.)
Known prior severe hypersensitivity (NCI CTCAE v5.0 Grade ≥ 3) to investigational product (IP) or any component in its formulations. This includes hypersensitivity or history of intolerance to steroids, 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 intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
Subjects currently taking prohibited medications as described in the protocol.

What this trial measures

  • Completion rate of 9 cycles of treatmentAt the end of 9 cycles of treatment (each cycle is 28 days)

    Assess the feasibility of approach incorporating the use of isatuximab and dexamethasone with the subsequent addition of lenalidomide from the third cycle onwards in ultra-frail patients with myeloma