Daratumumab With DCEP for Multiple Myeloma With Plasmacytoma

NCT04065308 | Unknown Phase 2 FDA Drug

• 1 other identifier: 1803-019-927
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Complete response rate in terms of plasmacytoma

  disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow

  within 4 weeks after the 3 cycles of combination therapy (daratumumab plus DCEP)

Secondary Outcomes (5)

• Response rate (Complete response + Partial Response) by IMWG criteria

  within 4 weeks after the 3 cycles of combination therapy (daratumumab plus DCEP)

• CR rate by IMWG criteria

  within 4 weeks after the 3 cycles of combination therapy (daratumumab plus DCEP)

• Progression free survival

  3,6,12,24 months after the last administration of daratumuamb

• Overall Survival

  3,6,12,24 months after the last administration of daratumuamb

• Safety and toxicity profile

  3,6,12,24 months the first administration of daratumumab

Study Arms (1)

Experimental arm

EXPERIMENTAL

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

Drug: Drug Combinations

Interventions

Drug Combinations DRUG

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

Also known as: Daratumumab plus DCEP

Experimental arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status 2 or better Adequate physical condition that could tolerate cytotoxic chemotherapy judged by investigator Relapsed/Refractory Multiple myeloma with plasmacytoma Adequate cardiac function , hepatic and renal function Adequate hematopoietic function i. White blood cells ≥3000 ii. Absolute neutrophil count ≥1500 iii. Platelets ≥50,000 iv. Hemoglobin \>7.5mg/dL ( Transfusion is not permitted within 2 weeks.) v. Total bilirubin \<1.5 times upper limit of normal vi. AST and ALT \<1.5 times upper limit of normal vii. Serum creatinine \<1.5 times upper limit of normal Singed and dated informed consent of document indicating that the patient(or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment For women of child bearing age, it should be confirmed that they are not pregnant and that they should be contraception during the study period and for up to 3 months after the end of study Male should agree to the barrier method during the study period and up to 3 months after the end of the study

You may not qualify if:

• HSCT (hematopoietic stem cell transplantation) within the last 12 weeks
• Other severe acute or

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Plasmacytoma

Interventions

Drug Combinations; daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• YOUNGIL KOH, MD., Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• JEONGOK LEE, MD., Ph.D.

  Seoul National University Bundang Hospital

  STUDY DIRECTOR

Central Study Contacts

YOO MI HWANG, CRN

CONTACT

821091186121; hym1530@gmail.com

HEE RYEONG JANG, MD

CONTACT

821077997052; wopower@naver.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 22, 2019
• Study Start: January 14, 2019
• Primary Completion: December 21, 2019
• Study Completion: September 30, 2021
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Time Frame: IPD will be shared after the publication of the study results without time limit.
• Access Criteria: IPD will be shared only for the research purpose.

Locations

KR (1)