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Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02477891
Expanded Access Status : Available
First Posted : June 23, 2015
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The objective of this study is to provide early access to daratumumab treatment and collect additional safety data while the medication is not commercially available or available through another protocol for subjects with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD.

Condition or disease Intervention/treatment
Multiple Myeloma Drug: Daratumumab

Detailed Description:
This is a multicenter, open-label, early access treatment protocol of single-agent daratumumab in subjects with multiple myeloma who have received at least 3 prior lines of therapy including a PI and an IMiD or whose disease is double refractory to both a PI and an IMiD, who reside in areas where daratumumab is not commercially available or available through another protocol, who have not been enrolled in another daratumumab study, and who are not eligible for or who do not have access to enrollment in another ongoing clinical study of daratumumab. The study will have three phases: Screening phase (30 days prior to first dose of study drug), treatment phase (until documented progression, unacceptable toxicity, or study end), End of Treatment (30 days after last dose of study drug). Participants will receive daratumumab (16 milligram per kilogram [mg/kg]) as intravenous infusion. Participants will primarily be assessed for overall response rate. Safety will be monitored throughout the study.

Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: An Open-Label Treatment Use Protocol for Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and an Immunomodulatory Agent) or Are Double Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent



Intervention Details:
  • Drug: Daratumumab
    Participants will receive daratumumab (16 milligram per kilogram [mg/kg]) as intravenous infusion on Day 1, 8, 15, and 22 of Cycles 1 and 2 (weekly dosing), on Day 1 and 15 of Cycles 3 to 6 (every 2 weeks dosing), and on Day 1 of Cycle 7 and subsequent cycles (every 4 weeks dosing) until documented progression, unacceptable toxicity, or study end. Each cycle is of 28 days.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be at least 18 years of age
  • Subject must have documented multiple myeloma and have evidence of disease progression on or after the most recent prior treatment regimen as defined by IMWG criteria: Subjects who have received at least 3 prior lines of therapy including a proteasome inhibitor (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an IMiD (>= 2 cycles or 2 months of treatment) in any order during the course of treatment (except for subjects who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months) OR Subjects whose disease is double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD). For subjects who have received more than 1 type of PI, their disease must be refractory to the most recent one. Similarly, for those who have received more than 1 type of IMiD, their disease must be refractory to the most recent one
  • Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • A woman of childbearing potential must have a negative serum or urine pregnancy test at Screening
  • 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 during the study, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug

Exclusion Criteria:

  • Ever enrolled in another daratumumab study or eligible for enrollment in another ongoing clinical study of daratumumab
  • Subject receives any other anti-myeloma therapy while receiving daratumumab
  • Enrolled in another interventional clinical study with therapeutic intent
  • Subject has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal
  • Subject has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification
  • Prior exposure to any anti-CD38 monoclonal antibody

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): NCT02477891


Contacts
Contact: For more information, please email 844-434-4210 JNJ.CT@sylogent.com

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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02477891     History of Changes
Other Study ID Numbers: CR106626
54767414MMY3010 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018

Keywords provided by Janssen Research & Development, LLC:
Multiple myeloma
Daratumumab
Early access

Additional relevant MeSH terms:
Daratumumab
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
Antibodies, Monoclonal
Proteasome Inhibitors
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action