Gentler myeloma treatment shows promise for frail patients
NCT ID NCT05911321
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a combination of three drugs—isatuximab, pomalidomide, and dexamethasone—at lower doses than usual. It includes 6 patients with multiple myeloma that has returned or not responded to treatment, who are also vulnerable due to age or other health problems. The goal is to see if this gentler approach is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- isatuximab, pomalidomide, and dexamethasone
- What this could lead to
- If this works, it could offer a safer treatment option for multiple myeloma patients who are older or have other health issues.
- What could go wrong
- This is a very small early-phase trial with only 6 participants, so results may not apply broadly. Lower doses might also be less effective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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6 people
The number who actually took part.
- Started
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Dec 2023
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information (PHI). Consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. 2. Age ≥ 18 years at the time of consent. 3. Documented symptomatic multiple myeloma that has previously responded to therapy (partial response or better) and is relapsed or relapsed and refractory to the last line of therapy. 4. Patients must also be refractory to at least one prior line of therapy that includes an IMiD and/or a PI, and should have received at least 2 cycles of that regimen to be evaluable for refractoriness . 5. If previously treated with an anti-CD38 containing regimen, the subject must have achieved at least a PR to that line of therapy and must not have received an anti- CD38 mAb for at least 6 months prior to enrollment. 6. Willing and able to adhere to the study visit schedule and other protocol requirements based on the judgement of the investigator. 7. Predicted high risk for severe toxicity from intensive regimens for RRMM, such as standard (full-dose) DPD, DVD, KPD, KRD, Ixa-PD, or Elo-PD as each regimen was published (such regimens often use, for example, twice-weekly bortezomib at 1.3 mg/m2, lenalidomide at 25 mg, or pomalidomide 4 mg). High-risk is defined as one of the following: A. Score ≥ 2 (indicating "frail") on the International Myeloma Working Group instrument (IMWG; Palumbo et al. \[Blood 2015\]) B.KPS ≤ 70 C. Not meeting criteria A or B above but felt by treating clinician to not be a candidate for a standard full-dose regimen on account of one of the following: i) History of clinically significant non-hematologic grade ≥3 (NCI CTCAE, version 5.0) toxicity attributed to prior anticancer therapy ii) History of requiring dose-reduction of at least two separate anticancer drugs during prior therapy for multiple myeloma. Exclusion Criteria: All subjects meeting any of the listed exclusion criteria at baseline with be excluded from study participation. 1. Anti-myeloma treatment within 2 weeks of cycle 1 day 1 2. Prior treatment with pomalidomide 3. Any monoclonal antibody therapy within the previous 30-days 4. Anti-CD38 monoclonal antibody therapy within the previous 6 months 5. Autologous stem cell transplantation within 12 weeks of day 1 of cycle 1 6. Subjects felt to not be candidates by treating physician for any systemic therapy due to excessive comorbidities, frailty, impaired performance status, or other severe limitations. Such limitations can be conceptualized generally as making subjects exceedingly high risk for any systemic treatment. These limitations often stem from medical comorbidities unrelated to MM and they are hence unlikely to improve with MM therapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
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Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514, United States
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