A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma
NCT ID: NCT02951819
Last Updated: 2021-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2016-11-09
2020-08-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dara-CyBorD
Subjects will receive Daratumumab along with Cyclophosphamide, Bortezomib and Dexamethasone (Dara-CyBorD) as induction on a 28-day cycle length and Daratumab and Dexamethasone on Day 1 of each cycle for 12 cycles as maintenance therapy.
Daratumumab
For induction therapy cycle 1 day 1 and day 2 doses of daratumumab will be 8 milligram/kilogram (mg/kg). Starting cycle 1 week 2 until the completion of week 8 of daratumumab patients will receive 16 mg/kg Intravenously (IV) weekly.
Starting week 9 until the completion of week 24 therapy daratumumab will be administered every other week at 16 mg/kg IV.
Starting week 25 and beyond for induction therapy daratumumab will be given once every 4 weeks.
Cyclophosphamide
Subjects will receive 4 to 8 cycles of oral cyclophosphamide 300 milligram per meter square (mg/m\^2 ) on Days 1, 8, 15, and 22 for every 28 days.
Bortezomib
Subjects will receive 4 to 8 cycles of Bortezomib 1.5 mg/m2 subcutaneous (SC) on Days 1, 8, and 15 for every 28 days.
Dexamethasone
Subjects will be given corticosteroids (Dexamethasone) as pre-infusion therapy prior to daratumumab and for the first 8 cycles will also receive post-infusion corticosteroids (Dexamethasone).
Interventions
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Daratumumab
For induction therapy cycle 1 day 1 and day 2 doses of daratumumab will be 8 milligram/kilogram (mg/kg). Starting cycle 1 week 2 until the completion of week 8 of daratumumab patients will receive 16 mg/kg Intravenously (IV) weekly.
Starting week 9 until the completion of week 24 therapy daratumumab will be administered every other week at 16 mg/kg IV.
Starting week 25 and beyond for induction therapy daratumumab will be given once every 4 weeks.
Cyclophosphamide
Subjects will receive 4 to 8 cycles of oral cyclophosphamide 300 milligram per meter square (mg/m\^2 ) on Days 1, 8, 15, and 22 for every 28 days.
Bortezomib
Subjects will receive 4 to 8 cycles of Bortezomib 1.5 mg/m2 subcutaneous (SC) on Days 1, 8, and 15 for every 28 days.
Dexamethasone
Subjects will be given corticosteroids (Dexamethasone) as pre-infusion therapy prior to daratumumab and for the first 8 cycles will also receive post-infusion corticosteroids (Dexamethasone).
Eligibility Criteria
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Inclusion Criteria
* Subjects with previously untreated myeloma or relapsed myeloma with one prior line of therapy including an induction regimen which may be followed by autologous stem cell transplantation and single agent maintenance therapy. For previously untreated subjects an emergency course of steroids (defined as no greater than 40 milligram (mg) of dexamethasone, or equivalent per day for a maximum of 4 days) is permitted. In addition, radiation therapy is permitted prior to study entry, during screening, and during Cycles 1-2 of study treatment as needed for lytic bone disease
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* A woman of childbearing potential must have 2 negative serum (beta (β) human chorionic gonadotropin) or urine pregnancy tests during screening, the first one within 28 days prior to the first dose of study drug and the second within 24 hours prior to the first dose of study drug
* A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug
Exclusion Criteria
* Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma
* Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) less than (\<) 50 percent (%) of predicted normal
* Has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification
* Is known to be seropositive for human immunodeficiency virus, known to have hepatitis B surface antigen positivity, or known to have a history of hepatitis C
18 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Scientific Affairs, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Scientific Affairs, LLC
Locations
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Mobile, Alabama, United States
Phoenix, Arizona, United States
Sedona, Arizona, United States
Tucson, Arizona, United States
Fayetteville, Arkansas, United States
Greenbrae, California, United States
Denver, Colorado, United States
Niles, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Bethesda, Maryland, United States
Columbia, Maryland, United States
Grand Rapids, Michigan, United States
Omaha, Nebraska, United States
Camden, New Jersey, United States
Albany, New York, United States
East Setauket, New York, United States
Fresh Meadows, New York, United States
Cincinnati, Ohio, United States
Eugene, Oregon, United States
Greenville, South Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Seattle, Washington, United States
Countries
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References
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Yimer H, Melear J, Faber E, Bensinger WI, Burke JM, Narang M, Stevens D, Gray KS, Lutska Y, Bobba P, Qi K, Hoehn D, Qi M, Lin TS, Rifkin RM. Daratumumab, cyclophosphamide, bortezomib, and dexamethasone for multiple myeloma: final results of the LYRA study. Leuk Lymphoma. 2022 Oct;63(10):2383-2392. doi: 10.1080/10428194.2022.2076847. Epub 2022 Jun 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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54767414MMY2012
Identifier Type: OTHER
Identifier Source: secondary_id
CR108235
Identifier Type: -
Identifier Source: org_study_id
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