A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM)



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:9/19/2018
Start Date:April 26, 2018
End Date:October 28, 2020
Contact:Takeda Study Registration Call Center
Email:globaloncologymedinfo@takeda.com
Phone:+1-866-835-2233

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A Phase 1/2a Open-label, Dose-Escalation Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Patients With Relapsed/Refractory Multiple Myeloma

The purpose of this study is to assess the safety, tolerability, maximum tolerated dose
(MTD)/recommended phase 2 dose (RP2D) in Phase 1 of the study and to provide a preliminary
evaluation of the clinical activity of TAK-079 monotherapy in participants with r/r MM in
Phase 2a of the study.

The drug being tested in this study is called TAK-079. TAK-079 is being tested to treat
people who have r/r MM. This study will assess the safety, tolerability, efficacy,
pharmacokinetics, and immunogenicity of TAK-079 monotherapy and will provide a preliminary
assessment of its activity against MM. The study is designed to consist of 2 phases: Phase 1
and Phase 2a.

The study will enroll approximately 42 participants. The study population of Phase 1 will
consist of approximately 24 participants. Participants in Phase 1 will be assigned to TAK-079
and dose-escalation will range from 45 mg to 1800 mg.

In Phase 1, participants will receive premedications 1 to 3 hours prior to the administration
of TAK-079 on each dosing day, as follows:

- Dexamethasone 20 mg

- Acetaminophen 650 to 1000 mg

- Diphenhydramine 25 to 50 mg

- Montelukast 10 mg

The study population of Phase 2a will consist of approximately 18 participants. Dose and
premedications for Phase 2a will be based upon review of the available safety, efficacy,
pharmacokinetic, and pharmacodynamic data from the preceding cohorts of Phase 1.

This multi-center trial will be conducted in the United States. The overall time to
participate in this study is 48 months (4 years). In Phase 1, participants who stop treatment
for any other reason other than PD will continue to have progression-free survival (PFS)
follow-up at the site every 4 weeks from the last dose of study drug up to 12 months or until
PD, death, loss to follow-up, consent withdrawal or study termination. Participants will be
followed 30 days after last dose of study drug or until the start of subsequent alternative
anti-cancer therapy, whichever occurs first, for a follow up assessment.

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of <=2.

2. Has received previous myeloma-specific therapy.

3. Requires additional therapy, as determined by the investigator.

4. Documentation of r/r MM as defined by the International Myeloma Working Group (IMWG)
criteria.

5. For Participants with MM, measurable disease defined as one of the following:

- Serum M-protein >=500 mg/dL (>=5 gram per liter [g/L]).

- Urine M-protein >=200 mg/24 hours.

- In participants without measurable M-protein in serum protein electrophoresis
(SPEP) or urine protein electrophoresis (UPEP), a serum FLC assay result with
involved FLC level >=10 mg/dL (>=100 milligram per liter [mg/L]), provided serum
FLC ratio is abnormal.

6. Prior therapy should include at least a proteasome inhibitor (PI), an immunomodulatory
drug (IMid), an alkylating agent, and a steroid and should be refractory or intolerant
to at least 1 PI and at least 1 IMid.

Note:

o Refractory is defined as at least a 25% increase in M-protein or PD during treatment or
within 60 days after cessation of treatment.

Exclusion Criteria:

1. Sensory or motor neuropathy of National Cancer Institute Common Terminology Criteria
for Adverse Events (NCI CTCAE) Grade >=3.

2. Have received allogeneic stem cell transplant.

3. Have received anti-CD38 antibody therapy and do not fulfill a 120-day washout period
before receiving TAK-079.

4. Not recovered from adverse reactions to prior myeloma treatment or procedures
(chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade <=1 or baseline.

5. Clinical signs of central nervous system (CNS) involvement of MM.

6. Active chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active
HIV, or cytomegalovirus (CMV) infection.

7. POEMS (Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin
changes) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma,
solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, or IgM myeloma.

8. Positive Coombs tests at screening.
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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