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Daratumumab With DCEP for Multiple Myeloma With Plasmacytoma (Dara_DCEP)

Primary Purpose

Multiple Myeloma in Relapse, Plasmacytoma, Daratumumab

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Drug Combinations
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma in Relapse

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental arm

Arm Description

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) dexamethasone :40mg/day D1-4, intravenous cyclophosphamide: 400mg/m2 D1-4, intravenous etoposide: 40mg/m2 D1-4, intravenous cisplatin : 7mg/m2 D1-4, intravenous Pegteograstim: 6mg once, SC on day 5 or 6 of each 28-day cycle

Outcomes

Primary Outcome Measures

Complete response rate in terms of plasmacytoma
disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow

Secondary Outcome Measures

Response rate (Complete response + Partial Response) by IMWG criteria
Complete response rate in terms of plasmacytoma plus partial response rate by IMWG criteria
CR rate by IMWG criteria
Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow
Progression free survival
from the last administration date of daratumumab to the date of disease progression or date from any cause
Overall Survival
from the last administration date of daratumumab to death from any cause
Safety and toxicity profile
according to CTCAE version 4.03

Full Information

First Posted
August 21, 2019
Last Updated
August 21, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04065308
Brief Title
Daratumumab With DCEP for Multiple Myeloma With Plasmacytoma
Acronym
Dara_DCEP
Official Title
A Phase II Trial to Evaluate the Efficacy of Daratumumab With DCEP in Multiply Myeloma Patients With Plasmacytoma Who Fail to Achieve Complete Remission With Bortezomib Containing Induction Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
December 21, 2019 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
This trial aimed to investigate the therapeutic efficacy of daratumumnab plus chemitherapy in multiple myeloma with plasmacytoma.
Detailed Description
Multiple myeloma with plasmacytoma is a disease with significantly short overall survival. Cancer cells in plasmacytoma has inferior response compared to cancer cells in bone marrow in multiple myeloma. It is revealed that genetic difference such as CCND1 overexpression and RAS mutation exists between plasmacytoma and intramedullary plasma cell myeloma, implying different treatment strategy should be applied to overcome poor prognosis of this distinct disorder. Even in the era of potent IMiDs and proteasome inhibitors, median overall survival of multiple myeloma patients with plasmacytoma is less than 5 years. Moreover, relapse in a form of soft tissue plasmacytoma is frequently observed after triplet combination treatment in multiple myeloma. Hence, multiple myeloma with plasmacytoma is a disease where unmet medical need still exists. Biologically, plasmacytoma is characterized by high plasma cell proliferation, angiogenesis gene profile, and adhesion molecule changes mimicking solid tumor . Responsiveness to chemotherapy used in myeloma including IMIds5 and proteasome inhibitor6 is obtuse in plasmacytoma. Only small fraction of young patients receiving high-dose chemotherapy followed by autologous stem cell transplantation may overcome adverse prognostic impact of plasmacytomas . Even it is recommended that VTD-PACE would be used as the first line treatment for plasmacytomas. In summary, cancer cells in plasmacytoma bear biologic characteristics of solid tumor cells and do respond to high-dose chemotherapy. And this phenomenon is very similar to lymphoma for the following reasons. Like lymphoma, 1) plasmacytoma express tumor antigen strongly (CD38 or CD138), 2) they form a solid mass, and 3) respond to cytotoxic chemotherapy in a dose-response manner. Considering the success story of rituximab in lymphoma, we conjecture that daratumumab may work excellently to control plasmacytoma. Hence, we propose a treatment regimen consists of DCEP chemotherapy and daratumumab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma in Relapse, Plasmacytoma, Daratumumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
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) dexamethasone :40mg/day D1-4, intravenous cyclophosphamide: 400mg/m2 D1-4, intravenous etoposide: 40mg/m2 D1-4, intravenous cisplatin : 7mg/m2 D1-4, intravenous Pegteograstim: 6mg once, SC on day 5 or 6 of each 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Drug Combinations
Other Intervention Name(s)
Daratumumab plus DCEP
Intervention Description
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) dexamethasone :40mg/day D1-4, intravenous cyclophosphamide: 400mg/m2 D1-4, intravenous etoposide: 40mg/m2 D1-4, intravenous cisplatin : 7mg/m2 D1-4, intravenous Pegteograstim: 6mg once, SC on day 5 or 6 of each 28-day cycle
Primary Outcome Measure Information:
Title
Complete response rate in terms of plasmacytoma
Description
disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow
Time Frame
within 4 weeks after the 3 cycles of combination therapy (daratumumab plus DCEP)
Secondary Outcome Measure Information:
Title
Response rate (Complete response + Partial Response) by IMWG criteria
Description
Complete response rate in terms of plasmacytoma plus partial response rate by IMWG criteria
Time Frame
within 4 weeks after the 3 cycles of combination therapy (daratumumab plus DCEP)
Title
CR rate by IMWG criteria
Description
Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow
Time Frame
within 4 weeks after the 3 cycles of combination therapy (daratumumab plus DCEP)
Title
Progression free survival
Description
from the last administration date of daratumumab to the date of disease progression or date from any cause
Time Frame
3,6,12,24 months after the last administration of daratumuamb
Title
Overall Survival
Description
from the last administration date of daratumumab to death from any cause
Time Frame
3,6,12,24 months after the last administration of daratumuamb
Title
Safety and toxicity profile
Description
according to CTCAE version 4.03
Time Frame
3,6,12,24 months the first administration of daratumumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: HSCT (hematopoietic stem cell transplantation) within the last 12 weeks Other severe acute or
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YOO MI HWANG, CRN
Phone
821091186121
Email
hym1530@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
HEE RYEONG JANG, MD
Phone
821077997052
Email
wopower@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YOUNGIL KOH, MD., Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JEONGOK LEE, MD., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YOOMI HWANG, CRN
Phone
821091186121
Email
hym1530@gmail.com
First Name & Middle Initial & Last Name & Degree
HEERYEONG JANG, MD., PhD
Phone
821077997052
Email
wopower@naver.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD regarding participant demographics, study treatment, response, survival, and adverse events will be shared after publishment of the study results.
IPD Sharing Time Frame
Time Frame: IPD will be shared after the publication of the study results without time limit.
IPD Sharing Access Criteria
IPD will be shared only for the research purpose.

Learn more about this trial

Daratumumab With DCEP for Multiple Myeloma With Plasmacytoma

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