RecruitingPhase 1NCT03909412

Carfilzomib Based Chemotherapy Mobilization for Autologous Stem Cell Transplants in Multiple Myeloma

Phase I Study of Carfilzomib-based Chemotherapy Mobilization for Autologous Stem Cell Transplantation in Multiple Myeloma

Sponsor

Hackensack Meridian Health

Enrollment

18 participants

Start Date

Oct 8, 2019

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

This phase I study utilizes a 3+3 design with escalating cohorts of Carfilzomib at 20mg/m2, 27mg/m2, 36mg/m2, 45mg/m2, 56mg/m2, and 70mg/m2 to be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone and Granulocyte colony-stimulating factor (G-CSF)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called carfilzomib as part of the stem cell collection process — where your own stem cells are mobilized into the bloodstream, collected, and stored before a stem cell transplant — in people with multiple myeloma. **You may be eligible if...** - You have a confirmed diagnosis of multiple myeloma with measurable disease - You are scheduled for an autologous stem cell transplant (using your own stem cells) - You have adequate organ function and overall health **You may NOT be eligible if...** - You have severe heart, lung, kidney, or liver problems - You have an active uncontrolled infection - You have had a prior stem cell transplant that failed during collection 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

DRUGCarfilzomib

Carfilzomib will be administered over 10 minutes for the 20 mg/m2 and 27 mg/m2 dose and over 30 minutes for all higher doses.

DRUGCyclophosphamide

Cyclophosphamide dosed at 2gm/m2 administered over 1 hour.

DRUGDexamethasone

Dexamethasone 40mg IV/PO to be administered as a premedication.

DRUGGranulocyte Colony-Stimulating Factor

On day 7 subjects will initiate high dose G-CSF injections at 14mcg/kg daily (with a cap of 1440mcg daily).

Locations(1)

Hackensack Meridian Health - John Theurer Cancer Center

Hackensack, New Jersey, United States

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NCT03909412

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