Generic Plerixafor Efficacy of Autologous Hematopoietic Stem Cell Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-09

Study Completion Date

2020-11-30

Brief Summary

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Generic plerixafor use at reduced-dose for mobilization on HSCT transplant

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Detailed Description

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The objective of this study is to demonstrate that the use of a low dose of the generic form of a drug called plerixafor is effective in increasing the amount of hematopoietic cells (stem cells) in your blood, which will then be collected for your transplant. Plerixafor is a very effective medicine that is already used for this purpose, however its high cost limits its use in all patients.

Conditions

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Lymphoma Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel study comparing placebo vs generic plerixafor

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

The patient receive a subcutaenous application (placbe vs generic plerixafor)

Study Groups

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Generic plerixafor

Use a reduced-dose of generic plerixafor (0.12 mcg/Kg)

Group Type ACTIVE_COMPARATOR

Celrixafor

Intervention Type DRUG

Use a reduced-dose of generic plerixafor

Placebo

Use of a subcutaenous application of saline solution

Group Type PLACEBO_COMPARATOR

Celrixafor

Intervention Type DRUG

Use a reduced-dose of generic plerixafor

Interventions

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Celrixafor

Use a reduced-dose of generic plerixafor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with lymphoma or multiple myeloma who are candidates for autoHSCT
* Patients \> 18 years old who signed our informed consent
* Normal CBC count (Hb \> 10, WBC 4.0-11.00, plt \> 100,000)