Go-slow isatuximab and dexamethasone with later lenalidomide for ultra-frail multiple myeloma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 interventional trial for newly diagnosed, ultra-frail adults with multiple myeloma or plasma cell leukemia who have had no more than one prior treatment cycle. Treatment begins with isatuximab plus dexamethasone, and lenalidomide is introduced from the third cycle onward in a staggered "go-slow" schedule. The protocol emphasizes tolerability, adherence, and patient-reported quality of life, alongside standard safety monitoring. The study is led by the University of Utah at Huntsman Cancer Institute in collaboration with Sanofi and enrolls participants at the Salt Lake City site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Huntsman Cancer Institute at the University of Utah
  Salt Lake City, Utah, United States Recruiting
• University of Illinois Cancer Center
  Chicago, Illinois, United States Not yet recruiting

Study contacts

• Principal investigator: Ghulam Rehman Mohyuddin, MBBS — Huntsman Cancer Institute
• Study coordinator: Rachel Kingsford
• Email: rachel.kingsford@hci.utah.edu
• Phone: 801-585-0115

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.