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OPTIMOB STUDY: INTERIM ANALYSIS OF THIS NON-INTERVENTIONAL TRIAL IN GERMANY TO EVALUATE THE MOBILIZATION AND COLLECTION OF HEMATOPOIETIC STEM CELLS IN POOR MOBILIZERS
Author(s): ,
Max Bittrich
Affiliations:
University Hospital Würzburg,Würzburg,Germany
,
Katharina Kriegsmann
Affiliations:
University Hospital Heidelberg,Heidelberg,Germany
,
Carola Tietze-Bürger
Affiliations:
University Hospital Charité,Berlin,Germany
,
Matthias Grube
Affiliations:
University Hospital Regensburg,Regensburg,Germany
,
Vladan Vucinic
Affiliations:
University Hospital Leipzig,Leipzig,Germany
,
Daniela Wehler
Affiliations:
University Hospital Mainz,Mainz,Germany
,
Andreas Burchert
Affiliations:
University Hospital Gießen und Marburg GmbH,Marburg,Germany
,
Martin Schmidt-Hieber
Affiliations:
Carl-Thiem-Hospital Cottbus GmbH,Cottbus,Germany
,
Heinz Albert Dürk
Affiliations:
St. Barbara Hospital Hamm – location St. Josef,Hamm,Germany
,
Christian Kunz
Affiliations:
Westpfalz-Hospital Kaiserslautern,Kaiserslautern,Germany
Nicolaus Kröger
Affiliations:
University Hospital Hamburg-Eppendorf,Hamburg,Germany
EHA Library. Kunz C. 06/09/21; 324959; EP1239
Christian Kunz
Christian Kunz
Contributions
Abstract
Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

Abstract: EP1239

Type: E-Poster Presentation

Session title: Stem cell transplantation - Clinical

Background

Although most of the patients with multiple myeloma (MM) or lymphoma eligible for autologous stem cell transplantation (ASCT) mobilize enough hematopoietic stem cells (HSCs), there are also patients in which mobilization is more difficult and several apheresis (aph) sessions are needed. For those poor mobilizers (PMs), data will be collected across Germany and adequate mobilization strategies will be established.

Aims
Aim of the OPTIMOB study is to assess the current approach of HSC mobilization and collection, and ASCT in PM patients in Germany to eventually improve mobilization and transplantation strategies, especially in PM patients. 

Methods
The OPTIMOB study is an ongoing, prospective, non-interventional study including patients having MM or lymphoma who are eligible for ASCT. PMs are categorized as follows: (1) patient never achieved ≥ 20 CD34+ cells / µL before 1st aph (PM-A), (2) patient received plerixafor (PLX) at any time point of mobilization (PM-B), (3) the initially planned HSC yield had to be reduced (PM-C), or (4) patients have not received aph due to low CD34+ count in peripheral blood (PM-D). 

Results

Until data cut-off in November 2020, 461 patients participated in the study, of whom 37.6% were classified as PMs. Most patients (67%) suffered from MM. Notable, the share of PMs was nearly the same in both entities, MM and lymphoma. In general, PMs were older, mostly male and had a poorer Karnofsky score. 68.2% of the PMs received plerixafor during mobilization, mainly in combination with chemotherapy and/or G-CSF (granulocyte-colony stimulating factor). PLX administration led to a notably increase of CD34+ cells in peripheral blood in PM patients (at least two-fold).  Until data cut-off, 84.4% of the PMs were able to undergo aph. In general, patients with PLX supported mobilization had a higher mean total CD34+ collection result than PM patients without PLX administration (7.5 x106 cells/kg body weight (BW) [SD: ± 7.46] vs 5.2 x106 cells/kg BW [SD: ± 3.70]). Further, 72% of the PM patients treated with PLX (n=104) reached the total planned CD34+ collection target (median 6.0 x106 cells/kg BW) during aph whereas in patients without PLX administration, only 45.5% of the patients achieved this goal.  ASCT was feasible in 66.5% of the PM patients until data cut-off.

Conclusion

The ongoing OPTIMOB study provides comprehensive data of the current situation of MM and lymphoma patients classified as PMs in Germany. Data support that additive administration of PLX to established mobilization strategies leads to a sufficient mobilization and collection of HSCs PM patients.


This non-interventional study is sponsored by Sanofi.

Keyword(s): Apheresis, Autologous hematopoietic stem cell transplantation, Mobilization, Multiple myeloma

Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

Abstract: EP1239

Type: E-Poster Presentation

Session title: Stem cell transplantation - Clinical

Background

Although most of the patients with multiple myeloma (MM) or lymphoma eligible for autologous stem cell transplantation (ASCT) mobilize enough hematopoietic stem cells (HSCs), there are also patients in which mobilization is more difficult and several apheresis (aph) sessions are needed. For those poor mobilizers (PMs), data will be collected across Germany and adequate mobilization strategies will be established.

Aims
Aim of the OPTIMOB study is to assess the current approach of HSC mobilization and collection, and ASCT in PM patients in Germany to eventually improve mobilization and transplantation strategies, especially in PM patients. 

Methods
The OPTIMOB study is an ongoing, prospective, non-interventional study including patients having MM or lymphoma who are eligible for ASCT. PMs are categorized as follows: (1) patient never achieved ≥ 20 CD34+ cells / µL before 1st aph (PM-A), (2) patient received plerixafor (PLX) at any time point of mobilization (PM-B), (3) the initially planned HSC yield had to be reduced (PM-C), or (4) patients have not received aph due to low CD34+ count in peripheral blood (PM-D). 

Results

Until data cut-off in November 2020, 461 patients participated in the study, of whom 37.6% were classified as PMs. Most patients (67%) suffered from MM. Notable, the share of PMs was nearly the same in both entities, MM and lymphoma. In general, PMs were older, mostly male and had a poorer Karnofsky score. 68.2% of the PMs received plerixafor during mobilization, mainly in combination with chemotherapy and/or G-CSF (granulocyte-colony stimulating factor). PLX administration led to a notably increase of CD34+ cells in peripheral blood in PM patients (at least two-fold).  Until data cut-off, 84.4% of the PMs were able to undergo aph. In general, patients with PLX supported mobilization had a higher mean total CD34+ collection result than PM patients without PLX administration (7.5 x106 cells/kg body weight (BW) [SD: ± 7.46] vs 5.2 x106 cells/kg BW [SD: ± 3.70]). Further, 72% of the PM patients treated with PLX (n=104) reached the total planned CD34+ collection target (median 6.0 x106 cells/kg BW) during aph whereas in patients without PLX administration, only 45.5% of the patients achieved this goal.  ASCT was feasible in 66.5% of the PM patients until data cut-off.

Conclusion

The ongoing OPTIMOB study provides comprehensive data of the current situation of MM and lymphoma patients classified as PMs in Germany. Data support that additive administration of PLX to established mobilization strategies leads to a sufficient mobilization and collection of HSCs PM patients.


This non-interventional study is sponsored by Sanofi.

Keyword(s): Apheresis, Autologous hematopoietic stem cell transplantation, Mobilization, Multiple myeloma

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