Multiple Myeloma is a type of blood cancer in cells made in the bone marrow. Relapsed means the previous cancer treatment worked for a while but stopped working, over time. Refractory means people did not respond to previous cancer treatment. TAK-169 is a medicine that binds to the surface of multiple myeloma cells called CD38 cells. It delivers a dose of chemotherapy to the CD38 cells.
This study is in 2 parts.
The main aims of Part 1 of the study are to check how much TAK-169 a person can receive without getting side effects from it, and to work out the best dose of TAK-169 to give people to treat their cancer. The main aim of Part 2 of the study is to learn if the condition of people with multiple myeloma improves after treatment with TAK-169. Another aim is to check for side effects from TAK-169.
In Part 1, at the first visit, the study doctor will check who can take part. Participants who can take part will receive TAK-169 slowly through the vein (infusion). This will happen once a week during a 28-day cycle. Different small groups of participants will receive lower to higher doses of TAK-169. The study doctors will check for side effects after each dose of TAK 169. In this way, researchers can work out the best dose of TAK-169 to give participants in Part 2 of the study. Each participant will stay in the clinic for at least 24 hours after they have received their first infusion of TAK-169.
Once the best dose has been worked out, different small groups of participants will receive lower to higher doses of TAK-169 every 2 weeks, starting at the best dose.
In Part 2, at the first visit, the study doctor will check who can take part, as only some participants with multiple myeloma can take part.
Participants who previously did not respond to daratumumab or it worked for a while but stopped working, over time will have 1 of 2 treatments.
Participants who have never previously received other medicines that bind to the multiple myeloma CD38 cells can also take part. They will receive TAK-169 once a week.
All participants in Part 2 will receive the best dose of TAK-169 worked out in Part 1.
In both parts of the study, participants can receive TAK-169 for up to 1 year. They could receive TAK-169 for longer than 1 year if their multiple myeloma continues to improve or remains stable during treatment. After treatment has finished, participants will visit the clinic for a check-up every 12 weeks.
Condition or disease | Intervention/treatment | Phase |
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Relapsed and/or Refractory Multiple Myeloma | Drug: TAK-169 | Phase 1 |
The drug being tested in this study is called TAK-169. The study will evaluate the safety, tolerability, preliminary efficacy, PK, pharmacodynamics, and immunogenicity of TAK-169 monotherapy in participants with RRMM.
The study will be conducted in 2 phases: Dose Escalation Phase (Part 1) and an Expansion Phase (Part 2). The study will enroll approximately 81 to 102 participants (39 to 60 participants in Part 1 and approximately 54 participants in Part 2).
In the Dose Escalation Phase (Part 1), the starting dose level will be 50 microgram/kilogram (mcg/kg), once weekly. On the basis of investigator and sponsor review of available safety, PK, pharmacodynamic, and efficacy data from Cohort 1, the dose will be escalated in the subsequent cohorts to 100, 200, 335, 500, and 665 mcg/kg, once weekly. A separate dose escalation may also occur in which TAK-169 will be administered once every 2 weeks.
In the Expansion Phase (Part 2), the study will evaluate two types of RRMM cohorts: Daratumumab-relapsed or Refractory (RR) Cohorts (once weekly and once every 2 weeks TAK-169 administration) and an Anti-CD38 Therapy Naive Cohort (once weekly TAK-169 administration). The starting dose for each expansion cohort will be the MTD/RP2D (once weekly and once every 2 weeks) determined in Part 1 after review of the available safety, efficacy, PK, and pharmacodynamic data from the dose escalation phase of the study.
This multi-center trial will be conducted in the United States. The overall duration of the study is 34 months. Participants will be followed up for 30 days after the last dose of study drug for a follow-up assessment.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 102 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Phase 1, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TAK-169 in Patients With Relapsed or Refractory Multiple Myeloma |
Actual Study Start Date : | February 5, 2020 |
Estimated Primary Completion Date : | January 17, 2023 |
Estimated Study Completion Date : | January 17, 2023 |
Arm | Intervention/treatment |
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Experimental: Part 1: TAK-169 50 mcg/kg Once Weekly
TAK-169 50 microgram per kilogram (mcg/kg), infusion, intravenously, once weekly on Days 1, 8, 15, and 22 in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicity or withdraw from the study for other reasons.
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Drug: TAK-169
TAK-169 intravenous infusion.
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Experimental: Part 1: TAK-169 100 mcg/kg Once Weekly
TAK-169 100 mcg/kg, infusion, intravenously, once weekly on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD, unacceptable toxicity or withdraw from the study for other reasons.
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Drug: TAK-169
TAK-169 intravenous infusion.
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Experimental: Part 1: TAK-169 200 mcg/kg Once Weekly
TAK-169 200 mcg/kg, infusion, intravenously, once weekly on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD, unacceptable toxicity or withdraw from the study for other reasons.
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Drug: TAK-169
TAK-169 intravenous infusion.
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Experimental: Part 1: TAK-169 335 mcg/kg Once Weekly
TAK-169 335 mcg/kg, infusion, intravenously, once weekly on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD, unacceptable toxicity or withdraw from the study for other reasons.
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Drug: TAK-169
TAK-169 intravenous infusion.
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Experimental: Part 1: TAK-169 500 mcg/kg Once Weekly
TAK-169 500 mcg/kg, infusion, intravenously, once weekly on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD, unacceptable toxicity or withdraw from the study for other reasons.
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Drug: TAK-169
TAK-169 intravenous infusion.
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Experimental: Part 1: TAK-169 665 mcg/kg Once Weekly
TAK-169 665 mcg/kg, infusion, intravenously, once weekly on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD, unacceptable toxicity or withdraw from the study for other reasons.
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Drug: TAK-169
TAK-169 intravenous infusion.
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Experimental: Part 1: TAK-169 TBD Once Every Two Weeks
TAK-169 TBD, infusion, intravenously, once every 2 weeks on Days 1 and 15 in a 28-day treatment cycle until PD, unacceptable toxicity or withdraw from the study for other reasons. Dose escalation of TAK-169 will be based on the investigator and sponsor review of available safety, PK, pharmacodynamics, efficacy data in the previous cohort.
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Drug: TAK-169
TAK-169 intravenous infusion.
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Experimental: Part 2, Daratumumab RR: TAK-169 TBD Once Weekly
TAK-169 TBD, infusion, intravenously, once weekly in participants who are relapsed or refractory (RR) to daratumumab until PD, unacceptable toxicity or withdraw from the study for other reasons. Dose for Part 2 will be determined based on the review of the available safety, efficacy, PK, and pharmacodynamics data from Part 1 of this study.
|
Drug: TAK-169
TAK-169 intravenous infusion.
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Experimental: Part 2, Daratumumab RR: TAK-169 TBD Once Every Two Weeks
TAK-169 TBD, infusion, intravenously, once every 2 weeks in participants who are RR to daratumumab until PD, unacceptable toxicity or withdraw from the study for other reasons. Dose for Part 2 will be determined based on the review of the available safety, efficacy, PK, and pharmacodynamics data from Part 1 of this study.
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Drug: TAK-169
TAK-169 intravenous infusion.
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Experimental: Part 2, Anti-CD38 Therapy Naive MM: TAK-169 TBD Once Weekly
TAK-169 TBD, infusion, intravenously, once weekly in participants with MM who have never received anti-CD38 therapy until PD, unacceptable toxicity or withdraw from the study for other reasons. Dose for Part 2 will be determined based on the review of the available safety, efficacy, PK, and pharmacodynamics data from Part 1 of this study.
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Drug: TAK-169
TAK-169 intravenous infusion.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria Part 1
Must meet all of the following criteria for prior therapy:
With measurable disease, defined as at least 1 of the following:
Must meet the following clinical laboratory criteria at study entry:
Inclusion Criteria Part 2
Must meet all of the following criteria for prior therapy:
With measurable disease, defined as at least 1 of the following:
Must meet the following clinical laboratory criteria at study entry:
Exclusion Criteria:
Have received a final dose of any of the following treatments/procedures within the following minimum interval before the first dose of TAK-169:
Contact: Takeda Study Registration Call Center | +1-877-825-3327 | MedinfoUS@takeda.com |
United States, Florida | |
Mayo Clinic - Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32224 | |
United States, Minnesota | |
Mayo Clinic - Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 |
Study Director: | Medical Director | Takeda |
Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | July 10, 2019 | ||||||||||||||||
First Posted Date ICMJE | July 12, 2019 | ||||||||||||||||
Last Update Posted Date | March 26, 2021 | ||||||||||||||||
Actual Study Start Date ICMJE | February 5, 2020 | ||||||||||||||||
Estimated Primary Completion Date | January 17, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | A Study of TAK-169 in Participants With Relapsed or Refractory Multiple Myeloma | ||||||||||||||||
Official Title ICMJE | A Phase 1, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TAK-169 in Patients With Relapsed or Refractory Multiple Myeloma | ||||||||||||||||
Brief Summary |
Multiple Myeloma is a type of blood cancer in cells made in the bone marrow. Relapsed means the previous cancer treatment worked for a while but stopped working, over time. Refractory means people did not respond to previous cancer treatment. TAK-169 is a medicine that binds to the surface of multiple myeloma cells called CD38 cells. It delivers a dose of chemotherapy to the CD38 cells. This study is in 2 parts. The main aims of Part 1 of the study are to check how much TAK-169 a person can receive without getting side effects from it, and to work out the best dose of TAK-169 to give people to treat their cancer. The main aim of Part 2 of the study is to learn if the condition of people with multiple myeloma improves after treatment with TAK-169. Another aim is to check for side effects from TAK-169. In Part 1, at the first visit, the study doctor will check who can take part. Participants who can take part will receive TAK-169 slowly through the vein (infusion). This will happen once a week during a 28-day cycle. Different small groups of participants will receive lower to higher doses of TAK-169. The study doctors will check for side effects after each dose of TAK 169. In this way, researchers can work out the best dose of TAK-169 to give participants in Part 2 of the study. Each participant will stay in the clinic for at least 24 hours after they have received their first infusion of TAK-169. Once the best dose has been worked out, different small groups of participants will receive lower to higher doses of TAK-169 every 2 weeks, starting at the best dose. In Part 2, at the first visit, the study doctor will check who can take part, as only some participants with multiple myeloma can take part. Participants who previously did not respond to daratumumab or it worked for a while but stopped working, over time will have 1 of 2 treatments.
Participants who have never previously received other medicines that bind to the multiple myeloma CD38 cells can also take part. They will receive TAK-169 once a week. All participants in Part 2 will receive the best dose of TAK-169 worked out in Part 1. In both parts of the study, participants can receive TAK-169 for up to 1 year. They could receive TAK-169 for longer than 1 year if their multiple myeloma continues to improve or remains stable during treatment. After treatment has finished, participants will visit the clinic for a check-up every 12 weeks. |
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Detailed Description |
The drug being tested in this study is called TAK-169. The study will evaluate the safety, tolerability, preliminary efficacy, PK, pharmacodynamics, and immunogenicity of TAK-169 monotherapy in participants with RRMM. The study will be conducted in 2 phases: Dose Escalation Phase (Part 1) and an Expansion Phase (Part 2). The study will enroll approximately 81 to 102 participants (39 to 60 participants in Part 1 and approximately 54 participants in Part 2). In the Dose Escalation Phase (Part 1), the starting dose level will be 50 microgram/kilogram (mcg/kg), once weekly. On the basis of investigator and sponsor review of available safety, PK, pharmacodynamic, and efficacy data from Cohort 1, the dose will be escalated in the subsequent cohorts to 100, 200, 335, 500, and 665 mcg/kg, once weekly. A separate dose escalation may also occur in which TAK-169 will be administered once every 2 weeks. In the Expansion Phase (Part 2), the study will evaluate two types of RRMM cohorts: Daratumumab-relapsed or Refractory (RR) Cohorts (once weekly and once every 2 weeks TAK-169 administration) and an Anti-CD38 Therapy Naive Cohort (once weekly TAK-169 administration). The starting dose for each expansion cohort will be the MTD/RP2D (once weekly and once every 2 weeks) determined in Part 1 after review of the available safety, efficacy, PK, and pharmacodynamic data from the dose escalation phase of the study. This multi-center trial will be conducted in the United States. The overall duration of the study is 34 months. Participants will be followed up for 30 days after the last dose of study drug for a follow-up assessment. |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE | Relapsed and/or Refractory Multiple Myeloma | ||||||||||||||||
Intervention ICMJE | Drug: TAK-169
TAK-169 intravenous infusion.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||
Estimated Enrollment ICMJE |
102 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Estimated Study Completion Date ICMJE | January 17, 2023 | ||||||||||||||||
Estimated Primary Completion Date | January 17, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Inclusion Criteria Part 1
Inclusion Criteria Part 2
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT04017130 | ||||||||||||||||
Other Study ID Numbers ICMJE | TAK-169-1001 U1111-1224-6002 ( Other Identifier: WHO ) 2019-000931-24 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Takeda | ||||||||||||||||
Study Sponsor ICMJE | Takeda | ||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||
Investigators ICMJE |
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PRS Account | Takeda | ||||||||||||||||
Verification Date | March 2021 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |