Promising myeloma combo trial pulled before it began
NCT ID NCT04392648
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to test a new drug called TAK-573, given with steroids and other cancer drugs, for people with multiple myeloma that came back or didn't respond to treatment. The goal was to find a safe dose and see if it helps shrink tumors. However, the trial was withdrawn before any patients were enrolled, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Expected to start
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Jun 2020
An estimate. Start dates often move.
- Expected to finish
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Nov 2023
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Received \>=2 prior lines of therapy, including treatment with lenalidomide and a proteasome inhibitor. 2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3. With measurable disease, defined as at least 1 of the following: * Serum M protein \>=500 mg/dL (\>=5 gram per liter \[g/L\]) on serum protein electrophoresis (SPEP). * Urine M protein \>=200 mg/24 hours on urine protein electrophoresis (UPEP). * Serum FLC assay result with an involved FLC level \>=10 mg/dL (\>=100 milligram per liter \[mg/L\]), provided the serum FLC ratio is abnormal. 4. Has adequate organ function as determined by the following laboratory values: * Absolute neutrophil count (ANC) \>=1000 per cubic millimeter (/mm\^3) (\>=1.0\*10\^9 \[per liter\]/L) * Platelets \>=75,000/mm\^3 (\>=75\*10\^9/L) * Hemoglobin \>=80 g/L * Creatinine clearance \>=30 milliliter per minute (mL/min) * Total serum bilirubin \<=1.5\*upper limit normal (ULN), \>=2.0\*ULN for participants with Gilbert's syndrome * Liver transaminases (alanine aminotransferase \[ALT\]/ aspartate aminotransferase \[AST\]) Serum ALT or AST \<=3.0\*ULN (\<5\*ULN if enzyme elevations are due to MM-related diffuse hepatic infiltrations). 5. Has received the final dose of any of the following treatments/procedures within the specified minimum intervals before first dose of TAK-573: * Chemotherapy, including proteasome inhibitors and immunomodulatory imide drug.(IMiDs) 14 days * Antimyeloma antibody therapy 21 days * Corticosteroid therapy for myeloma 7 days * Radiation therapy for localized bone lesions 7 days * Major surgery 21 days. Exclusion Criteria: 1. Has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia or IgM myeloma, lymphoplasmacytic lymphoma, or plasma cell leukemia. 2. Previous intolerance to combination agent. 3. For the pomalidomide expansion group only: no prior treatment with pomalidomide. 4. Inability to take prophylaxis needed for combination agent (deep vein thrombosis prophylaxis for pomalidomide, antiviral prophylaxis for proteasome inhibitor). 5. Who have received autologous stem cell transplant (SCT) within 60 days before first infusion of TAK-573 or participants who have received allogeneic SCT 6 months before first infusion. Graft-versus-host disease that is active or requires ongoing systemic immunosuppression. 6. Has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade \<=1 or baseline, except for sensory or motor neuropathy which should have recovered to Grade \<=2 or baseline, Grade \<2 for participants receiving bortezomib. 7. Has a chronic condition requiring the use of systemic corticosteroids \>10 milligram per day (mg/day) of prednisone or equivalent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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