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Phase II study of efficiency of peripheral blood stem cell harvest using low-dose cyclophosphamide plus G-CSF for multiple myeloma

LDCY-MM study

20

Data were collected for 20 consecutive patients with multiple myeloma in a single institution. The number of Male is 16. Of female are 4. The median age was 60.5years(range,37-67) For the induction therapy, Of 11(55%) were performed by VRD(bortezomib, lenalidomide, dexamethasone(DEX) and of 9 (45%) were received VCD(bortezomib, cyclophosphamide, dexamethasone(DEX). As for the original presence of had illnesses, of 7 had hypertension, of 2 had DM and 3of had hyperlipidemia.

This study was conducted in accordance with the ethical guidelines mandated by the Declaration of Helsinki. The goal was to enroll 22 participants at first. Finally, 20 patients were participated. All patients signed informed consent forms approved by the institutional review board at Chiba University hospital. A total of 20 patients were enrolled into this analysis without premature termination or suspension of a trial. CY was given at low dose as previously defined at day 1and G-CSF was administered s.c.at 10ug/kg/day starting at day 2 following CY treatment. All PBSC collections were performed with a Sectra Optia Apheresis System and measurements of CD34+ cell content in apheresis product were performed by the FACS Calibur flow cytometer. The harvested cells were cryopreserved in 10% DESMO using a controlled-rate freezer. After the mobilization, all patients received conditioning with melpharan 200mg/mm on day -2, followed by infusion of PBSCs on day0. As for engraftment, neutrophil engraftment was considered the first of 3 consecutive days with absolute neutrophil count >=0.5*(10*9)/L. Platelet engraftment was considered the first of 3 successive days with platelet count >= 20*(10*9)/L.

One participant became pneumonia. Hospitalization for side effect was required only one of 20 patients (5%). He was treated with infusion of antimicrobial agents and got well soon. There were no lethal adverse events in this study.

For the purpose of this study, the cell dose target for transplantation was at least 2*(10*6) CD34+ cell/kg. Of17 patients were good mobilizers. All patients proceeded to HDT and autologous HCT. There was no engraftment failure. Mobilization outcomes are presented as follows: The median volume of PBSC was 199ml(range,118-298), the median run time was 311min(range,146-334),the median volume of total processed blood was 12255 ml(range,5906-14065) and the median CD34+ cells/kg after first mobilization was 5.68*(10*6) CD34+ cell/kg (range,0.45-9.85). Also results of secondary endpoints are presented as follows: The median time to neutrophils engraftment was day12 (10-31). Toxicities (Grade3) occurred in 1 of 22 patients (5%). This mobilization protocol was well tolerated.

The CY dose used for PBSC mobilization in patients with MM varied widely (range1-7g/mm). In this study, we analyzed the importance of cyclophosphamide dose intensity on PBSCH mobilization comparing with previous report. Of 85% were successfully mobilized stem cells. Low dose CY regimen decreased infectious complications and morbidity

June. 08, 2024

No

None

https://jrct.niph.go.jp/latest-detail/jRCTs031180336

Sakaida Emiko

Department of Hematology, Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba

esakaida@faculty.chiba-u.jp

Mitsukawa Shio

Department of Hematology, Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba

+81-43-222-7171

shio-sakai@chiba-u.jp

Complete

June. 01, 2015

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

1) Patients diagnosed with multiple myeloma based on IWMG criteria
2) Bone marrow plasma cells under 5% after chemotherapy
3) Lenalidomide treatment under 4 cycles
4) More than 4 weeks after the beginning day of the last chemotherapy
5) Age 20-70
6) ECOG PS 0-2
7) Within 14 days prior to registration
Neutrophil over 1,000/mm3
Hemoglobin over 8.0g/dl
Platelet over 100,000/mm3
GOT, GPT under 2.5 times the upper limit of normal level
Total bilirubin under 2.0mg/dl
Creatinine under 2.0mg/dl
ECG WNL or trivial change without any symptoms
SpO2 over 95%
8) More than 3 months survival expected
9) Informed consent obtained

1) Pregnant or lactating females. Patients who cannot do contraception.
2) Complications of active other cancers.
3) Severe psychological disorder
4) HBsAg positive or HBV-DNA positive.
5) HIV-Ab positive.
6) Plasma cells in the peripheral blood.
7) Severe drug allergy.
8) Active infection.
9) Any other problems regarded as disqualification by doctors.

Both

Multiple myeloma

Treatment by cyclophosphamide, mesna, graniserton, and lenograstim. Autologous peripheral blood stem cell harvest (auto-PBSCH)

Multiple myeloma

PBSCH, cyclophosphamide, lenograstim

Success rate of PBSCH to obtain 2 times10^6/kg CD34 positive cells for a transplantation

effectiveness
Day of engraftment

safety
Frequency of adverse events (any grade/grade 3 and more), frequency of adverse response against drugs

+81-43-226-2616

Feb. 20, 2019

none