RecruitingPhase 2NCT04240054

Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency

A Multisite, Phase II Study of Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone (VICD) Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency


Sponsor

Medical College of Wisconsin

Enrollment

41 participants

Start Date

Nov 2, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open-label phase II study with a safety lead-in phase.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of four drugs — bortezomib, isatuximab, cyclophosphamide, and dexamethasone — as an initial treatment for patients newly diagnosed with multiple myeloma (a type of blood cancer) before they undergo a stem cell transplant. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with multiple myeloma (confirmed by bone marrow test and organ damage criteria) - You are eligible for high-dose chemotherapy and stem cell transplant - You have received little to no prior treatment for multiple myeloma (limited short-term treatment is acceptable) - You are in reasonably good overall health **You may NOT be eligible if...** - You have already received extensive prior treatment for multiple myeloma - You have a different type of plasma cell disorder (not myeloma) - You are not a candidate for stem cell transplant - You are pregnant or breastfeeding - You have serious uncontrolled infections or organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBortezomib

Bortezomib (1.5 mg/m\^2) subcutaneous on days 1, 8 and 15

DRUGIsatuximab

Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22

DRUGCyclophosphamide

Cyclophosphamide (250 mg/m\^2) IV on days 1, 8 and 15

DRUGDexamethasone

Dexamethasone 20 mg PO or IV (10 mg if \>75 years) on days 1, 2, 8, 9, 15, 16, 22 and 23


Locations(1)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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NCT04240054


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