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Granulocyte Colony-Stimulating Factor · 1 trial · 1 indication
Safety and tolerability will be assessed by clinical review of all relevant parameters including Adverse Events (CTCAE v4.0)
To determine the maximum tolerated dose (MTD) of carfilzomib in combination with cyclophosphamide, dexamethasone and G-CSF in mobilizing and collecting peripheral blood stem cells
| Arm | Type | Description |
|---|---|---|
| Carfilzomib Mobilization - Dose Level 0 | EXPERIMENTAL | Carfilzomib at 20mg/m2 over 10 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing. |
| Carfilzomib Mobilization - Dose Level 1 | EXPERIMENTAL | Carfilzomib at 27mg/m2 over 10 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing. |
| Carfilzomib Mobilization - Dose Level 2 | EXPERIMENTAL | Carfilzomib at 36mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing. |
| Carfilzomib Mobilization - Dose Level 3 | EXPERIMENTAL | Carfilzomib at 45mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing. |
| Carfilzomib Mobilization - Dose Level 4 | EXPERIMENTAL | Carfilzomib at 56mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing. |
| Carfilzomib Mobilization - Dose Level 5 | EXPERIMENTAL | Carfilzomib at 70mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing. |
| Name | Type | Description |
|---|---|---|
| Carfilzomib | DRUG | 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. |
| Cyclophosphamide | DRUG | Cyclophosphamide dosed at 2gm/m2 administered over 1 hour. |
| Dexamethasone | DRUG | Dexamethasone 40mg IV/PO to be administered as a premedication. |
| Granulocyte Colony-Stimulating Factor | DRUG | On day 7 subjects will initiate high dose G-CSF injections at 14mcg/kg daily (with a cap of 1440mcg daily). |
INCLUSION CRITERIA Subject has voluntarily agreed to participate by giving written informed consent 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 c...
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Granulocyte Colony-Stimulating Factor is being studied for use in Multiple Myeloma as part of a Phase 1 clinical trial. The trial combines it with carfilzomib-based chemotherapy to mobilize autologous stem cells for transplantation in patients with this condition.
Granulocyte Colony-Stimulating Factor targets the granulocyte colony-stimulating factor receptor, which stimulates the production and release of neutrophils from the bone marrow. In the context of this trial, it is used to mobilize stem cells from the bone marrow into the bloodstream for collection prior to autologous stem cell transplantation.
Granulocyte Colony-Stimulating Factor is being developed by Meridian Bioscience Inc, a company traded under the ticker symbol VIVO. The company is conducting a Phase 1 clinical trial of this agent in Multiple Myeloma.
Granulocyte Colony-Stimulating Factor is in Phase 1 clinical development. It is an investigational agent being studied in a single active trial for Multiple Myeloma, and it has not yet been approved by regulatory authorities for this indication.
Granulocyte Colony-Stimulating Factor is being evaluated in clinical trial NCT03909412, titled 'Carfilzomib Based Chemotherapy Mobilization for Autologous Stem Cell Transplants in Multiple Myeloma.' This Phase 1 trial is recruiting 18 participants in the United States and is not randomized or double-blinded.
Granulocyte Colony-Stimulating Factor is commonly known as G-CSF. In this clinical trial, it is used in combination with carfilzomib-based chemotherapy to mobilize stem cells for autologous transplantation in patients with Multiple Myeloma.