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RecruitingPhase 2

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

Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma: A Phase 2 Multicenter Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a slow, gentle way to start treatment for very frail adults with newly diagnosed multiple myeloma or plasma cell leukemia, cancers of plasma cells in the blood and bone marrow. Treatment starts with isatuximab and dexamethasone, then slowly adds lenalidomide starting with the third treatment cycle. Researchers want to learn if this helps people stay on treatment and improves their quality of life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have newly diagnosed myeloma or plasma cell leukemia confirmed by a tissue test, and have had no more than one treatment cycle.
  • Your frailty score is 3 or higher on the IMWG scale, which measures how frail you are.
  • You have a negative pregnancy test if you could become pregnant, or proof of menopause or surgery that prevents pregnancy. Menopause means no periods for 24 months with no other medical cause.
  • You agree to follow the birth control rules, join the lenalidomide REMS safety program, and sign the Patient-Physician Agreement Form.
  • Men must agree to use latex condoms during sex throughout study treatment, even after a vasectomy.
  • Side effects from past treatment are back to your usual level or are mild, unless the study doctor finds them minor or stable with care.
  • You can understand and agree to join the study and are willing to sign a consent form.

Who can't join

  • You are receiving other experimental treatments.
  • The study doctor finds a condition that makes participation unsafe or prevents you from understanding, agreeing to, or following study steps. Examples include infection, a blocked intestine, trouble swallowing pills, or social or mental health concerns. Study pills cannot be given through a feeding tube.
  • You have had a severe allergic reaction to a study drug or its ingredients, or cannot tolerate them, and medicines given before treatment cannot make further treatment possible.
  • You are taking medicines that the study rules do not allow.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

UT