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Trial record 1 of 1 for:    NCT02951819
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A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma

This study is currently recruiting participants.
Verified October 2017 by Janssen Scientific Affairs, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02951819
First Posted: November 1, 2016
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
  Purpose
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.

Condition Intervention Phase
Multiple Myeloma Drug: Daratumumab Drug: Cyclophosphamide Drug: Bortezomib Drug: Dexamethasone Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Daratumumab Plus Cyclophosphamide, Bortezomib and Dexamethasone (Dara-CyBorD) in Previously Untreated and Relapsed Subjects With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • Complete Response plus Very Good Partial (CR+VGPR) Response Rate [ Time Frame: Approximately 4 Months ]
    Percentage of subjects achieving complete response plus very good partial response rate (CR+VGPR) according to International Myeloma Working Group (IMWG) criteria.


Secondary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: Following 4 cycles (each cycle is of 28 days), end of induction (4-8 cycles), at start of maintenance therapy and after end of maintenance therapy (12 months) ]
    Percentage of subjects who achieve complete response (CR), very good partial response (VGPR) or partial response (PR) according to IMWG criteria.

  • Time to Very Good Partial Response (VGPR) or Better [ Time Frame: Up to End of Treatment (Approximately 36 months) ]
    Time to VGPR or better is defined as the duration from the date of start of induction therapy to the date of initial documentation of VGPR or better, which is confirmed by a repeated measurement as required by the IMWG criteria.

  • Time to Partial Response or Better [ Time Frame: Up to End of Treatment (Approximately 36 months) ]
    Time to partial response is defined as the duration from the date of start of induction therapy to the date of initial documentation of PR or better, which is confirmed by a repeated measurement as required by the IMWG criteria.

  • Duration of Response (DoR) [ Time Frame: Up to End of Treatment (Approximately 36 months) ]
    Duration of response is defined as the duration from the date of initial documentation of a response (PR or better) according to the IMWG criteria to the date of first documented evidence of progressive disease according to the IMWG criteria.

  • Progression Free Survival (PFS) Rate [ Time Frame: 36 Months (approximately at 1 year and 3 years) ]
    Percentage of subjects who have not developed progressive disease and are at alive at 1 year and 3 years after study entry.

  • Overall Survival Rate [ Time Frame: 36 Months (approximately at 1 year and 3 years) ]
    Percentage of subjects who are alive at 1 year and 3 years after study entry.

  • Number of Subjects with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to End of Treatment (Approximately 36 months) ]
  • Infusion Reaction Profile of Split-Dose Infusions of Daratumumab [ Time Frame: Day 1 and Day 2 of Cycle 1 ]
    Infusion reaction profile of split-dose infusions of daratumumab administered as 8 mg/kg on C1D1 and C1D2 by tabulating the incidence of infusion-related reactions by System-Organ Class and preferred term.


Estimated Enrollment: 100
Actual Study Start Date: November 9, 2016
Estimated Study Completion Date: December 25, 2020
Estimated Primary Completion Date: February 20, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.

Drug: 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.
Drug: 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.
Drug: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951819


Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Show 36 Study Locations
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
  More Information

Additional Information:
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT02951819     History of Changes
Other Study ID Numbers: CR108235
54767414MMY2012 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Submitted: October 31, 2016
First Posted: November 1, 2016
Last Update Posted: October 13, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Daratumumab
Cyclophosphamide
Bortezomib
BB 1101
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists