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Daratumumab With DCEP for Multiple Myeloma With Plasmacytoma

NCT04065308 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-08-22

No results posted yet for this study

Summary

This trial aimed to investigate the therapeutic efficacy of daratumumnab plus chemitherapy in multiple myeloma with plasmacytoma.

Conditions

  • Multiple Myeloma in Relapse
  • Plasmacytoma
  • Daratumumab

Interventions

DRUG

Drug Combinations

Daratumumab plus DCEP,combination therapy is administered total of three cycles,every 4weeks(28 days). Daratumuamb 16mg/kg body weight in 500mL (the first dose,16mg/kg body weight in 1000mL) Weeks 1 to 8: weekly Weeks 9-24 : every 2 weeks if ASCT ineligible or PR but Plasmacytoma response \<CR: every 2 weeks for 12weeks and then every 4 weeks for 8weeks (Total of 8 times, additional administration of daratumumab) if ASCT eligible: From 6 to 12 weeks after ASCT, administration of daratumumab is initiated within 12 weeks of ASCT and twice a month for 12 weeks and then every a months for 8 weeks. (Total of 8 additional administration of daratumumab after ASCT) 1. dexamethasone :40mg/day D1-4, intravenous 2. cyclophosphamide: 400mg/m2 D1-4, intravenous 3. etoposide: 40mg/m2 D1-4, intravenous 4. cisplatin : 7mg/m2 D1-4, intravenous Pegteograstim: 6mg once, SC on day 5 or 6 of each 28-day cycle

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • YOUNGIL KOH, MD., Ph.D · Seoul National University Hospital

  • JEONGOK LEE, MD., Ph.D. · Seoul National University Bundang Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2019-12-21
Completion
2021-09-30
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04065308 on ClinicalTrials.gov