YCUMM-1401:Efficacy of VRD and Lenalidomide therapy after autologous stem cell transplantation for multiple myeloma patients

YCUMM-1401:Efficacy of VRD and Lenalidomide therapy after autologous stem cell transplantation for multiple myeloma patients - MM1401:VRD/R trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014038

Enrollment

Registered

2014-06-01

Start date

2014-06-01

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

bortezomib 1.3 mg/m2 s.c day1,8,15 lenalidomide 10 mg/body p.o. day1-21 dexamethasone 40 mg/body p.o. day1,8,15 repeat 4 times on every 28 days lenalidomide 10mg/body/day p.o. 21days every 28 da

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with symptomatic myeloma as criteria of International Myeloma Working Group (IMWG), and received autologous stem cell transplantation (ASCT) - high dose chemotherapy (HDT) 2. Patients with VGPR, PR or SD efficacy after ASCT 3. Patients with good general condition (ECOG Performance Status, PS 0-2) 4. Patients with mainteinedvisceral function a. SpO2 > 94 % b. 1) granulocyte count; 1000/microL 2) platelet count; 50000/microL c. renal function: independent from dialysis d. liver function 1) total bilirubin; 1.5xN 2) AST ; 2.5xN 3) ALT ; 2.5xN 5. Patients who can avoid pregnancy 6. Patients with informed concent 7. Patients who can presercve RevMate

Exclusion criteria

Exclusion criteria: 1. Patients who have allergic history for bortezomib, lenalidomide, or dexamethasone. 2. Patients who diagnosed with malignancy of plasma cell other than myekoma. 3. Patient who cannot expect to survive more than 3 months. 4. Patients who have other active malignancy within past 5 years 5. Patients with positivity of HBs antigen, HCV antibody, or HIV antibody. 6. Patients with periferal neuropathy of CTCAE Grade 2-4. 7. Patients with severe active infection. 8. Patients with severe mental disturbance. 9. Patient with severe respiratory impairment. 10. Patients with interstitial pneumonia or pulmonary fiblosis. 11. Patients with severe cardiac dysfunction 12. Patients with uncontroled diabetes mellitus. 13. Patients who need dialysis. 14. Patients with severe liver dysfunction 15. Patients with pregnant or lactating 16. Patients who are considerded unsuitable for the trial by attending physician.

Design outcomes

Primary

Measure	Time frame
progression free survival	—

Secondary

Measure	Time frame
overall survival efficacy rate of VRD therapy completion rate of VRD therapy adverse event rate	—

Countries

Japan

Contacts

Public ContactEtsuko Yamazaki

Yokohama City University Hospital Clinical Laboratory Department

etsukoy@yokohama-cu.ac.jp045-787-2800

Outcome results

None listed

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