Back to resultsA Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DFRF4539A
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Adult patients; >/= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Relapsed or refractory multiple myeloma for which no effective standard therapy exists
- One of the prior therapies must have included a proteosome inhibitor or an immunomodulatory drug
- Measurable disease as defined by protocol
Exclusion Criteria:
- Prior use of monoclonal antibody within 4 weeks before Cycle 1, Day 1
- Treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1
- Toxicities from any previous treatment must be resolved prior to Cycle 1, Day 1, except for neuropathy
- Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
- Prior allogeneic stem cell transplant
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
- Grade > 1 peripheral neuropathy
- Active infection at screening or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to Cycle 1, Day 1
- Positive for hepatitis B, hepatitis C or HIV infection
- Pregnant or lactating women or women who intend to become pregnant within the period of time of this study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Safety: Incidence of adverse events
Safety: Maximum tolerated dose/dose-limiting toxicities
Recommended Phase II dose for every-3-week or weekly administration of DFRF4539A
Secondary Outcome Measures
Immunogenicity: Serum antitherapeutic antibody levels
Pharmacokinetics: Area under the concentration - time curve (AUC)
Objective response, tumor assessments according to International Myeloma Working Group (IMWG) Uniform Response Criteria and/or European Bone Marrow Transplant (EBMT) Criteria
Duration of objective response, defined as time from first documented objective response to progression or death of any cause
Progression-free survival, defined as time from first study treatment (Cycle 1, Day 1) to disease progression or death during study or within 30 days after last dose of study drug, whichever occurs first
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01432353
Brief Title
A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma
Official Title
An Open-label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
Brief Summary
This multicenter, open-label, dose-escalating study will assess the safety and efficacy of DFRF4539A in patients with relapsed or refractory multiple myeloma. Cohorts of patients will receive multiple ascending doses of intravenous DFRF4539A every 3 weeks or weekly. Patients exhibiting acceptable safety and evidence of clinical benefit may receive DFRF4539A for up to 17 cycles. Anticipated time on study treatment is 1 year or until disease progression or unacceptable toxicity occurs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DFRF4539A
Intervention Description
multiple ascending doses
Primary Outcome Measure Information:
Title
Safety: Incidence of adverse events
Time Frame
approximately 3.5 years
Title
Safety: Maximum tolerated dose/dose-limiting toxicities
Time Frame
approximately 1.5 years
Title
Recommended Phase II dose for every-3-week or weekly administration of DFRF4539A
Time Frame
approximately 3.5 years
Secondary Outcome Measure Information:
Title
Immunogenicity: Serum antitherapeutic antibody levels
Time Frame
approximately 3.5 years
Title
Pharmacokinetics: Area under the concentration - time curve (AUC)
Time Frame
approximately 3.5 years
Title
Objective response, tumor assessments according to International Myeloma Working Group (IMWG) Uniform Response Criteria and/or European Bone Marrow Transplant (EBMT) Criteria
Time Frame
approximately 3.5 years
Title
Duration of objective response, defined as time from first documented objective response to progression or death of any cause
Time Frame
approximately 3.5 years
Title
Progression-free survival, defined as time from first study treatment (Cycle 1, Day 1) to disease progression or death during study or within 30 days after last dose of study drug, whichever occurs first
Time Frame
approximately 3.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients; >/= 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Relapsed or refractory multiple myeloma for which no effective standard therapy exists
One of the prior therapies must have included a proteosome inhibitor or an immunomodulatory drug
Measurable disease as defined by protocol
Exclusion Criteria:
Prior use of monoclonal antibody within 4 weeks before Cycle 1, Day 1
Treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1
Toxicities from any previous treatment must be resolved prior to Cycle 1, Day 1, except for neuropathy
Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
Prior allogeneic stem cell transplant
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
Grade > 1 peripheral neuropathy
Active infection at screening or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to Cycle 1, Day 1
Positive for hepatitis B, hepatitis C or HIV infection
Pregnant or lactating women or women who intend to become pregnant within the period of time of this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma
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