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A Phase 2, single arm, open label, multicenter study to assess minimal residual disease after isatuximab in combination with bortezomib and lenalidomide with minimal dexamethasone in patients with newly diagnosed multiple myeloma ineligible for autologous transplant.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510194-34-00
Enrollment
51
Registered
2024-10-09
Start date
2021-06-18
Completion date
Unknown
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma

Brief summary

The proportion of patients who achieve MRD negativity measured by NGF Euroflow during/or after first 18 Cycles of study treatment.

Detailed description

The proportion of patients who achieve PR or better after 2 cycles of IVRd followed by 6 cycles of IVR, followed by 10 cycles of IR., The PFS rate, The OS rate, The number of AEs and relevant laboratory parameters monitored at every visit (see SoA) from inclusion until end of study., The change in HRQL trajectories and steroid toxicity over time (day 22 – day 1) during IVRd (cycle 1 and 2) compared to IVR (cycle 4 and 5).

Interventions

DRUGISATUXIMAB
DRUGLENALIDOMIDE
DRUGDEXAMETHASONE
DRUGBORTEZOMIB

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The proportion of patients who achieve MRD negativity measured by NGF Euroflow during/or after first 18 Cycles of study treatment.—

Secondary

MeasureTime frame
The proportion of patients who achieve PR or better after 2 cycles of IVRd followed by 6 cycles of IVR, followed by 10 cycles of IR., The PFS rate, The OS rate, The number of AEs and relevant laboratory parameters monitored at every visit (see SoA) from inclusion until end of study., The change in HRQL trajectories and steroid toxicity over time (day 22 – day 1) during IVRd (cycle 1 and 2) compared to IVR (cycle 4 and 5).—

Countries

Denmark, Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026