NCT02221479

A Randomized, Open-label, Two-arm Parallel Group, Comparative Study for Assessing the Clinical Benefit of Subcutaneous Injection of Plerixafor Plus G-CSF for Mobilization and Collection of Peripheral Hematopoietic Stem Cells in Japanese Patients With Multiple Myeloma

Completed Phase 2 Last updated 3 August 2015

What this trial tests

Phase 2 trial testing plerixafor GZ316455 in Multiple Myeloma in 14 participants. Completed in 1 July 2015.

Timeline

1 October 2014

Primary endpoint
1 July 2015

1 July 2015

Quick facts

Lead sponsor	Genzyme, a Sanofi Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	1 October 2014
Primary completion	1 July 2015
Estimated completion	1 July 2015
Sites	5 locations across Japan

Drugs / interventions tested

• plerixafor GZ316455 — full drug profile →
• Filgrastim — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Genzyme, a Sanofi Company — full company profile →

Who can join

Adults 20 to 75, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Proportion of participants who achieve a collection of greater than or equal to 6 x10^6 cells/kg CD34+ cells in less than or equal to 2 days of apheresis
  Time frame: Day 5 to Day 8 of the apheresis/treatment period

Sponsor's own description

Primary Objective:

To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 6 x 10\^6 cluster of differentiation (CD) 34+ cells/kg in 2 or fewer days of apheresis than MM patients mobilized with G-CSF alone.

Secondary Objectives:

* To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in MM patients.
* To compare the 2 treatment arms with respect to the number of participants who achieved a minimum of 2 x 10\^6 CD34+ cells/kg in 4 or fewer days of apheresis.
* To compare the 2 treatment arms with respect to the number of days of apheresis required to reach the target of greater than or equal to 6 x 10\^6 CD34+ cells/kg.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of HMGB1 in Chemotherapy-Induced Peripheral Neuropathy.
   Sekiguchi F, Kawabata A. · · 2020 · cited 23× · PMID 33396481 · DOI 10.3390/ijms22010367
2. Additional plerixafor to granulocyte colony-stimulating factors for haematopoietic stem cell mobilisation for autologous transplantation in people with malignant lymphoma or multiple myeloma.
   Hartmann T, Hübel K, Monsef I, Engert A, et al · · 2015 · cited 15× · PMID 26484982 · DOI 10.1002/14651858.cd010615.pub2
3. G-CSF + plerixafor versus G-CSF alone mobilized hematopoietic stem cells in patients with multiple myeloma and lymphoma: a systematic review and meta-analysis.
   Li Y, Qiu X, Lei Y, Zhou R. · · 2024 · cited 3× · PMID 38470973 · DOI 10.1080/07853890.2024.2329140