Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant

Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant - Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021864

Enrollment

Registered

2016-05-15

Start date

2016-05-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Interventions

Patients receive bortezomib (1.3mg/2 day4,7), cyclophosphamide (1g/m2 day1) and G-CSF (days 4-) and begin apheresis on day 8. Patients undergo apheresis for up to 2 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Diagnosis with multiple myeloma and eligible for 1st autologous transplantation (2)ECOG performance status 0-2 (3)WBC >2.5x109/L, Neutrophil 1.2x109/L, Platelet count >100x109/L (4)AST, ALT, T-Bil less than two times the upper limit of normal (5)Serum Cr =< 2mg/dl (6)Left ventricular ejection fraction => 50% (7)SpO2 =>95% (8)Voluntary written informed consent form before performance of any study-related procedure

Exclusion criteria

Exclusion criteria: (1)Patient has hypersensitivity to bortezomib, cyclophosphamide, and G-CSF. (2)Patient has Grade =>2 peripheral neuropathy (3)Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, cardiac amyloidosis (4)Known interstitial Pneumonitis (5)Uncontrolled intercurrent infection (6)Known HBs antigen positive, HCV antibody positive (7)Known HTLV-I antibody positive, HIV antibody positive (8)Female patients who are pregnant and/or breastfeeding. (9)Active gastrointestinal bleeding (10)Serious psychiatric illness (11)A co-morbid condition which, in the view of the investigators, renders the patient at high risk for this study

Design outcomes

Primary

Measure	Time frame
Successful mobilization (Single collection:>4x106/kg CD34 positive cell) rate	—

Countries

Japan

Contacts

Public ContactMasahide Yamamoto

Tokyo Medical and Dental University Department of Hematology

hide.hema@tmd.ac.jp03-5803-5211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026