Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma
Recruiting
Phase 2
Interventional Study
Multiple Myeloma
Plasma Cell Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- University of Utah · Other
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About This Trial
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, m…
Trial Locations
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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 pos…
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