Status:
COMPLETED
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)
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Relapsed/Refractory
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the safety and tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-079 monotherapy and when combined with a backbone regimen of pom...
Detailed Description
The drug being tested in this study is called TAK-079. TAK-079 is being tested to treat people who have relapsed and/or refractory multiple myeloma (RRMM). This study will assess the safety, tolerabil...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status of \<=2.
- Has received previous myeloma-specific therapy.
- In the Combination Cohort (TAK-079-PomDex) only must be able to take concurrent prophylactic anticoagulation per standard clinical practice as directed by the investigator and the Pomalyst product information.
- Documentation of RRMM as defined by the International Myeloma Working Group (IMWG) criteria.
- For Participants with MM, measurable disease defined as one of the following:
- Serum M-protein \>=0.5 g/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.
- Prior therapy should meet all the following criteria:
- Participants in the dose Escalation Cohort (escalation phase) and participants in the dose Confirmation Cohort;
- Should be previously treated with at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and a steroid. Note: Participants who have had a previous autologous stem cell transplant will have additionally been exposed to an alkylating agent; however, participant who have not had a previous autologous stem cell transplant may not have been exposed to an alkylating agent per standard practice.
- Should be refractory or intolerant to at least 1 PI and at least 1 IMiD.
- Should either have received \>= 3 prior lines of therapy or should have received at least 2 prior lines of therapy if one of those lines included a combination of PI and IMiD.
- In phase 1, previous exposure to an anti-CD38 agent, as a single agent or in combination, is allowed but is not required. (Participants in the dose Escalation Cohort).
- In phase 1 dose Confirmation Cohort, cohorts of participants that are refractory at any time to at least 1 anti-CD38 agent or who are anti-CD38 naïve will be enrolled.
- Participants in the Combination Cohort (TAK-079 added to PomDex cohort only):
- Have undergone prior therapy with \>=2 prior anti-myeloma therapies (line of therapy defined below).
- Has either relapsed or relapsed and refractory disease. Should have progressed on or within 60 days of completing the last anti-myeloma therapy (refractory defined below).
- In the phase 2a portion of the study, up to 2 cohorts of participants with RRMM may be enrolled: 1 that is refractory to at least 1 anti-CD38 monoclonal antibody (mAb) therapy at any time during treatment and 1 that is naïve to daratumumab.
- Note:
- o Refractory is defined as at least a 25% increase in M-protein (response of stable disease during prior therapy) or PD during treatment or within 60 days after last dose of prior therapy.
Exclusion
- Sensory or motor neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade \>=3.
- Have received allogeneic stem cell transplant.
- Have received anti-CD38 antibody therapy and do not fulfill a 180-day washout period before receiving TAK-079.
- Not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade \<=1 or baseline, excluding alopecia.
- Clinical signs of central nervous system (CNS) involvement of MM.
- Active chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active HIV, or cytomegalovirus (CMV) infection.
- 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.
- Positive Coombs tests at screening.
- For participants in the Combination Cohort (TAK-079-PomDex) only: participant has previously received pomalidomide or has hypersensitivity to thalidomide or lenalidomide.
Key Trial Info
Start Date :
April 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03439280
Start Date
April 20 2018
End Date
January 28 2022
Last Update
February 24 2023
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope - Duarte
Duarte, California, United States, 91010
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
3
Mount Sinai Hospital-The Donald H. Ruttenberg Cancer Treatment Center
New York, New York, United States, 10011
4
Weill Cornell Medical Center, Div. of Hematology Medical Oncology
New York, New York, United States, 10065