Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly NDMM
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- STATUS
- Recruiting
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- End date
- Jun 10, 2028
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- participants needed
- 38
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- sponsor
- Ajai Chari
Summary
This is a single center, open-label, phase 2 study in elderly (age 70) subjects with newly diagnosed multiple myeloma who are transplant ineligible. Subjects will receive subcutaneous daratumumab, dose-attenuated bortezomib, revlimid, and dexamethasone until confirmed disease progression, discontinuation of study treatment due to unacceptable drug toxicity, or other reasons. Throughout the study, subjects will be monitored closely for adverse events, laboratory abnormalities, and clinical response.
Description
This is a single center, open-label, phase 2 study in elderly (age 70) subjects with newly diagnosed multiple myeloma who are transplant ineligible. The main study consists of the following phases: a 28-day screening phase; followed by initial therapy with 12 cycles of daratumumab in combination with dose-attenuated VRd; and a maintenance phase that starts after Cycle 12 of therapy. Cycles are 28 days in length. Treatment can continue until disease progression or unacceptable toxicity. After 12 cycles of initial therapy, maintenance therapy will begin with 28 day cycles of daratumumab with either lenalidomide or ixazomib and the choice of maintenance therapy will be based on cytogenetic risk status at diagnosis. All subjects will continue maintenance treatment until disease progression, except maintenance daratumumab will be discontinued after 2 years if subjects remain on maintenance treatment at that time. All subjects will be followed in the longterm follow-up for at least 1 year after last dose of study treatment and will continue until death, withdrawal of consent for study participation, or the end of study definition is met. The end of study is defined as when all subjects have completed at least 1 year of long-term follow up and until death, withdrawal of consent for study participation, or 5 years after first patient begins daratumumab therapy, whichever occurs first.
Details
| Condition | Newly Diagnosed Multiple Myeloma |
|---|---|
| Treatment | Dexamethasone, Lenalidomide, Bortezomib, Daratumumab, Ixazomib |
| Clinical Study Identifier | NCT04052880 |
| Sponsor | Ajai Chari |
| Last Modified on | 16 February 2022 |
Eligibility
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