Multiple MyelomaPhase 2UltraFrailMMNCT06517017
Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma
A Phase 2 study testing Isatuximab in people with Multiple Myeloma and Plasma Cell Leukemia, run by University of Utah at 2 sites in United States.
Trial summary
Historically, the frailest patients with multiple myeloma are under-represented in clinical trials, and have very high rates of treatment discontinuation, and early treatment mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Plasma Cell Leukemia
- What is being tested?
- Isatuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Oct 2025to Nov 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Illinois Cancer Center
Chicago, Illinois, 60612
Sonubar Griffin, sonubarg@uic.edu
Ana Avila Rodriguez
- Recruiting
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
Rachel Kingsford, 801-585-0115, rachel.kingsford@hci.utah.edu
About this study
Official title: Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma: A Phase 2 Multicenter Study
Historically, the frailest patients with multiple myeloma are under-represented in clinical trials, and have very high rates of treatment discontinuation, and early treatment mortality. The investigators hypothesize that a go-slow gentle approach to starting treatment in such patients, starting with just Isatuximab and dexamethasone with a gentle introduction to lenalidomide third cycle onwards, may improve treatment adherence and quality of life. The goal of this clinical trial is to learn if a go-slow approach to treating MM in ultra-frail patients may improve the ability to adhere to treatment and improve quality of life.
- Conditions
- Multiple Myeloma, Plasma Cell Leukemia
- Being tested
- Isatuximab
- Medical subject headings
- Multiple Myeloma, Leukemia, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsatuximabDrug
Also called Dexamethasone, Lenalidomide
Subcutaneous isatuximab will be administered weekly on a 28-day cycle during the first two cycles, and every two weeks of a 28-day cycle thereafter. Dexamethasone will be administered on the days of isatuximab administration and can be discontinued after two cycles of therapy, or continued at discretion of investigator. Lenalidomide, will be added after two cycles of therapy have been completed.
| Study group | Role | What they receive |
|---|---|---|
| Combination Treatment | Experimental | Isatuximab Receives: Drug: Isatuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate of 9 cycles of treatment
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
Measured: At the end of 9 cycles of treatment (each cycle is 28 days)
Secondary outcomes (7)
Change in quality of life as per the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 domain
Assess if an approach incorporating the use of isatuximab and dexamethasone with the subsequent addition of a lenalidomide in ultra-frail patients with myeloma leads to an improvement in quality of life as measured by the EORTC score. The questionnaire has 10 subscales, each with a score range of 0 to 100 points. Higher scores on the functional scales and global quality of life indicate better functioning, while higher scores on the symptom scales indicate a higher symptom burden. The QLQ-C30 summary score is calculated by averaging the scores of the 13 scales and items, with a higher score indicating a better health-related quality of life (HRQoL).
Measured: At the end of 4 cycles of treatment (each cycle is 28 days)
Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type
Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population.
Measured: At study completion. Participants will be enrolled in study for about 3 years.
Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0)
Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population.
Measured: At study completion. Participants will be enrolled in study for about 3 years.
Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness
Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population.
Measured: At study completion. Participants will be enrolled in study for about 3 years.
Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration
Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population.
Measured: At study completion. Participants will be enrolled in study for about 3 years.
Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment
Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population.
Measured: At study completion. Participants will be enrolled in study for about 3 years.
Overall survival (OS)
Assess overall survival in this study population
Measured: Time from registration until 3 years from start of therapy or death from any cause.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start9 Oct 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm phase 2 study.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Ghulam Rehman Mohyuddin, MBBS, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517017
- Sponsor's protocol ID
- HCI171326
- Acronym
- UltraFrailMM
- Status last verified
- Oct 2026
- First submitted
- 12 Jul 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No