A Prospective Multicenter Randomized Phase III Study on The Effect of VCD or VTD Induction, High-Dose Therapy with Autologous Stem Cell Transplantation, and Bortezomib Maintenance in Patients with Newly Diagnosed Multiple Myeloma

A Prospective Multicenter Randomized Phase III Study on The Effect of VCD (Bortezomib, Cyclophosphamide, and Dexamethasone) or VTD (Bortezomib, Thalidomide, and Dexamethasone) Induction, High-Dose Therapy with Autologous Stem Cell Transplantation, and Bortezomib Maintenance in Patients with Newly Diagnosed Multiple Myeloma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0002959

Enrollment

294

Registered

2018-06-29

Start date

2018-10-22

Completion date

Unknown

Last updated

2022-11-28

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

Conditions

None listed

Interventions

Drug : (1) Arm A: 4 cycles of VCD (21 days) • Velcade 1.3mg/m2/day subcutaneous, day 1, 4, 8, 11 • Cyclophosphamide 300mg/m2/day, po day 1, 8, 15 • Dexamethasone 40mg/day, day 1, 4, 8, 11 (2) Arm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Newly diagnosed multiple myeloma(MM) (2) Age 18-64 years (3) The MM patients who have measurable disease at diagnosis (serum M-protein = 1 g/dL, urine M-protein = 200 mg/day) (4) ECOG perforemance status 0-2 (5) Adequate cardiac furnction (Ejection fraction = 50%) (6) Adequate liver, renal, and hematological function before ASCT - creatinine clearance = 30 mL/min - AST or ALT < 3 x upper normal value - Total bilirubin < 2 x upper normal value - platelet count = 75 x 10^9/L, Hgb = 8 g/dL, neutrophil count =1.0 x 10^9/L (7) Females of child-bearing portential must be negative in the pregnancy test ( urine or serum) before treatment. (8) Subjects must have signed an informed consent document indicating that they understand purpose of and procedures required for the study and are willing to participate in the study.

Exclusion criteria

Exclusion criteria: (1) Age = 65years (2) Primary amyloidosis, Smoldering MM, MGUS (3) Patients who received chemotherapy for MM (4) Prior history of malignancies, except completely cured non-melanoma skin cancer or in situ carcinoma of cervix uteri who (5) Patients who had peripheral neuropathy with = grade 2 (6) HIV patients (7) Active Hepatitis B or C (8) Pregnant or lactating woman or female of child bearing potential who is not contraceptive (9) Patients who have uncontrolled diabetes (10) Serious psychiatric illness likely to interfere with participation in this clinical study

Design outcomes

Primary

Measure	Time frame
Overall response rate after induction therapy;Progression free survival;Toxicity of induction therapy	—

Secondary

Measure	Time frame
Overall response rate after transplant;Safety after transplant;Non-relapse mortality;Overall survival	—

Countries

Korea, Republic of

Contacts

Public ContactSung-Hoon Jung

Chonnam National University Hospital Hwasun Hospital

shglory@hanmail.net+82-61-379-7629

Outcome results