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New treatment option for Multiple Myeloma
Official title Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma
ClinicalTrials.gov ID: NCT06517017
What this study is testing
What is Isatuximab?
Isatuximab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as Dexamethasone, Lenalidomide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 people of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical...
- people must be willing to follow contraception requirements listed in the protocol, agree to participate in the Lenalidomide REMS program, and have...
- Male people must agree to use a latex condom during intercourse for the duration of study therapy as described in the protocol, even if he has...
You likely can't join if
- 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...
- Known prior severe hypersensitivity (NCI CTCAE v5.0 Grade ≥ 3) to investigational product (IP) or any component in its formulations. This includes...
- people currently taking prohibited medications as described in the protocol.
See the full eligibility 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 people 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...
- people 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 people 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
- 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...
- 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...
- people currently taking prohibited medications as described in the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.