The purpose of this study is to assess the safety and tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose of TAK-079 monotherapy and when combined with a backbone regimen of pomalidomide and dexamethasone (PomDex) in Phase 1, and to provide a preliminary evaluation of the clinical activity of TAK-079 monotherapy in Phase 2a in participants with relapsed/refractory multiple myeloma.
The information from the study may be used to:
How many people will take part in the study?
It is planned that 24 patients with multiple myeloma will take part in Phase 1, and 18 patients will take part in Phase 2. The study is being carried out at multiple sites in the United States.
How Long Will I Be In the Study?
You can continue receiving TAK-079 unless your disease worsens or you experience unacceptable side effects or withdraw due to other reasons not listed. You will be followed for 30 (+/-7) days after your last dose of TAK-079 or right before the start of any subsequent anticancer therapy. If you discontinue treatment for any other reason then you will be followed every 4 weeks from end of treatment until progressive disease, consent withdrawal, or others reasons the study would end.
What Will Happen During the Study?
Phase 1 (dose escalation):
In Phase 1 of the study, patients will start receiving low doses of TAK-079. The lowest dose has already been given in healthy individuals. If that dose is well tolerated, the study will enroll the next group of 3 patients who will receive a little higher dose of TAK-079, and if that dose is well tolerated, the next group will receive the next higher dose, and so on until the best dose for TAK-079 is reached. There will be 6 planned dose levels for Phase I. However, if a certain level of toxicity is observed, the recommendation is to stop increasing doses.
Phase 2 (dose expansion):
In Phase 2 of the study, patients will receive the dose of TAK-079 found to be safe and well tolerated during the during the first phase of the study to check specifically the activity of TAK -079 against your disease. However, during this phase of the study, toxicity will be monitored as well. If a certain grade of toxicity has been seen observed, no more patients will be accepted to enter this study until further investigation. Only after further investigation has shown that continuation of the study is safe, the study will be re-opened again and new patients will be accepted again.
How Will Treatment Be Administered?
You will receive the study drug, TAK 079 by subcutaneous (under your skin) injections given every 30 minutes until the full scheduled dose has been administered.
You will receive TAK-079 at weekly intervals for 8 weeks. If you do not have any severe side effects, your cancer does not get worse, and your study doctor feels that you would continue to benefit from treatment with TAK 079, you will continue to receive treatments every 2 weeks for 16 weeks, and then once every 4 weeks unless your disease worsens or you experience unacceptable side effects.
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Prior therapy should meet all the following criteria:
Participants in the dose Escalation Cohort (escalation phase) and participants in the dose Confirmation Cohort;
Participants in the Combination Cohort (TAK-079 added to PomDex cohort only):
Note: 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.
The following is a listing of trial locations that are open and accepting patients.
November 13, 2019
In the 14 patients receiving at least 4 cycles of therapy by the time of the data cutoff, the objective response rate (ORR; partial response or better) was 43%, 1 patient's response deepened over time to VGPR, the clinical benefit rate (minimal response or better) was 57%. Within this group, in patients never exposed to anti-CD38 therapy, the ORR was 46%.
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