Clinical trial NCT02951819: A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma
Official title: Daratumumab Plus Cyclophosphamide, Bortezomib and Dexamethasone (Dara-CyBorD) in Previously Untreated and Relapsed Subjects With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate complete response plus (+) very good partial response (CR+VGPR) rate following 4 cycles of induction therapy of daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD), in previously untreated subjects, and in relapsed subjects with multiple myeloma, as defined by the International Myeloma Working Group (IMWG) criteria.


Eligibility criteria: Inclusion Criteria:

* Subjects with documented multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) 2015 criteria: Clonal bone marrow plasma cells greater than or equal to (\>=) 10 percent (%) or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following CRAB (calcium level, renal dysfunction, anemia, and destructive bone lesions) features and myeloma defining events as in the protocol
* 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:

* Refractory to any proteasome inhibitor (PI) or the combination of PI and immunomodulatory drug (IMiD) agents (such as lenalidomide), defined as failure to respond or progression within 60 days of the end of PI therapy
* 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

Primary outcomes:
measure: Percentage of Participants Who Achieved Complete Response (CR) or Very Good Partial Response (VGPR)
timeFrame: After 4 cycles of Induction (Approximately 4 months)
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: After 4 Cycles of Induction (4 months), at End of Induction (4 to 8 months) and at the End of Maintenance (12 months)
measure: Time to Very Good Partial Response (VGPR) or Better
timeFrame: Up to 36 months
measure: Time to Partial Response (PR) or Better
timeFrame: Up to 12 months
measure: Duration of Response (DOR)
timeFrame: Up to 36 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 36 months
measure: Time to Disease Progression (TTP)
timeFrame: Approximately 15 months
measure: Overall Survival (OS)
timeFrame: Up to 36 months
measure: Percentage of Participants With Treatment Emergent-Adverse Event
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Sedona
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Fayetteville
country: United States
state: Arkansas
city: Greenbrae
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Niles
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Bethesda
country: United States
state: Maryland
city: Columbia
country: United States
state: Maryland
city: Grand Rapids
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Camden
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: East Setauket
country: United States
state: New York
city: Fresh Meadows
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: Greenville
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: