DCY-MM study

Phase 2

• Conditions: Multiple myeloma

• Registration Number: JPRN-jRCTs031180336
• Lead Sponsor: Sakaida Emiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
effectiveness<br>Day of engraftment<br><br>safety<br> Frequency of adverse events (any grade/grade 3 and more), frequency of adverse response against drugs