Go-slow isatuximab and dexamethasone with later lenalidomide for ultra-frail multiple myeloma patients
Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma: A Phase 2 Multicenter Study
PHASE2 · University of Utah · NCT06517017
This trial will try a gentle, phased start of isatuximab and dexamethasone, adding lenalidomide later, for newly diagnosed, ultra-frail adults with multiple myeloma or plasma cell leukemia to help them stay on treatment and feel better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah (other) |
| Drugs / interventions | Isatuximab |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06517017 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) newly diagnosed with multiple myeloma or plasma cell leukemia who are considered ultra-frail and have received no more than one prior treatment cycle, and who can meet contraception and REMS requirements, are ideal candidates.
Not a fit: Patients who are relatively fit and can tolerate full-intensity standard regimens, or those with rapidly progressive disease needing immediate aggressive therapy, are unlikely to benefit from a gentler go-slow approach.
Why it matters
Potential benefit: If successful, this approach could help more ultra-frail patients complete therapy with fewer early discontinuations and better quality of life.
How similar studies have performed: Anti-CD38 antibody combinations with lenalidomide have shown benefit in multiple myeloma, but deliberately introducing lenalidomide later for ultra-frail patients is a relatively novel strategy with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Salt Lake City, Utah
- Huntsman Cancer Institute at the University of Utah — Salt Lake City, Utah, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Myeloma, Plasma Cell Leukemia