A Phase 1/2a Study Investigating TAK-079 Administered Subcutaneously in Patients With Relapsed/Refractory Multiple Myeloma

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Overview

The purpose of this study is to evaluate the safety, tolerability and identify the most appropriate dose, of TAK-079 monotherapy as treatment for patients with Relapsed/Refractory Multiple Myeloma. The study is also to obtain information on the amount of TAK-079 in your blood after taking single of the study drug.

The information from the study may be used to:

  • To develop a better understanding of how people’s genetic makeup and cell proteins affects the safety and effectiveness of TAK-079
  • To generate information needed for research, development and regulatory approval of TAK-079 and diagnostic tests related to diseases or conditions that TAK-079 might treat

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.

SparkCures ID 946
Trial Phase Phase 1/2
Enrollment 42 Patients
Treatments
Trial Sponsors
  • Takeda Oncology
NCT Identifier

NCT03439280

Am I Eligible?

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.

  • Are at least 18 years old
  • Have relapsed or refractory multiple myeloma
  • Have been treated with at least three prior lines of multiple myeloma therapy including a proteasome inhibitor, an immunomodulatory agent, an alkylating agent, and steroids OR 2 lines of prior therapy if one of the lines included a combination of a proteasome inhibitor and an immunomodulatory agent
  • Have not received allogeneic stem cell transplant.
  • Prior treatment with an anti-CD38 antibody is allowed; details should be discussed with your doctor

The following criteria is provided for health care professionals.

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 relapsed/refractory multiple myeloma 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: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.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

California
Missouri
Siteman Cancer Center<br />Washington University Medical Campus
New York
Mount Sinai Hospital<br />Tisch Cancer Institute
Weill Cornell Medicine<br />
Weill Cornell Medicine

New York, NY

Oregon
Texas
MD Anderson Cancer Center<br />The University of Texas
Wisconsin
Medical College of Wisconsin<br />Froedtert Hospital

Resources

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