A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01432353
• Collaborator: (none)
• Enrollment: 39
• Locations: 8
• Arm: 1
• Duration (Months): 31
• Patients Per Site: 4.9
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: DFRF4539A	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2011
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm	Drug: DFRF4539A; multiple ascending doses

Outcome Measures

Primary Outcome Measures

1. Safety: Incidence of adverse events [approximately 3.5 years]

2. Safety: Maximum tolerated dose/dose-limiting toxicities [approximately 1.5 years]

3. Recommended Phase II dose for every-3-week or weekly administration of DFRF4539A [approximately 3.5 years]

Secondary Outcome Measures

1. Immunogenicity: Serum antitherapeutic antibody levels [approximately 3.5 years]

2. Pharmacokinetics: Area under the concentration - time curve (AUC) [approximately 3.5 years]

3. Objective response, tumor assessments according to International Myeloma Working Group (IMWG) Uniform Response Criteria and/or European Bone Marrow Transplant (EBMT) Criteria [approximately 3.5 years]

4. Duration of objective response, defined as time from first documented objective response to progression or death of any cause [approximately 3.5 years]

5. 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 [approximately 3.5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Scottsdale	Arizona	United States	85259
2		Duarte	California	United States	91010
3		Jacksonville	Florida	United States	32224
4		Sarasota	Florida	United States	34232
5		Chicago	Illinois	United States	60611
6		Bethesda	Maryland	United States	20817
7		New York	New York	United States	10021
8		Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Genentech, Inc.

Investigators

• Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT01432353
• Other Study ID Numbers: FRF4998g; GO27825
• First Posted: Sep 13, 2011
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Nov 2, 2016