A Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combi… (NCT04392648) | Clinical Trial Compass
WithdrawnPhase 1
A Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Stopped: Business Decision (no enrollment)
0Started 2020-06-24
Plain-language summary
The purpose of this study is to determine the safety, tolerability, and recommended phase 2 dose (RP2D) of TAK-573 when used with dexamethasone and in combination with bortezomib, pomalidomide, or cyclophosphamide, in participants with RRMM.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Received \>=2 prior lines of therapy, including treatment with lenalidomide and a proteasome inhibitor.
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. With measurable disease, defined as at least 1 of the following:
✓. Has adequate organ function as determined by the following laboratory values:
✓. Has received the final dose of any of the following treatments/procedures within the specified minimum intervals before first dose of TAK-573:
Exclusion criteria
✕. 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.
✕. Previous intolerance to combination agent.
✕. For the pomalidomide expansion group only: no prior treatment with pomalidomide.
✕. Inability to take prophylaxis needed for combination agent (deep vein thrombosis prophylaxis for pomalidomide, antiviral prophylaxis for proteasome inhibitor).
✕. 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.
What they're measuring
1
Number of Participants who Experienced at Least one Treatment Emergent Adverse Event (TEAE)
Timeframe: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
2
Number of Participants with Clinically Significant Vital Signs Values, Clinically Significant Change From Baseline in Clinical Laboratory Values and 12-lead Electrocardiograms (ECG), and who Received any Concomitant Medications
Timeframe: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
3
Dose Expansion Phase: Overall Response Rate (ORR)
Timeframe: Cycle 17 up to 3 years (Cycle length is equal to [=] 21 days in Arm 4 and is = 28 days in Arms 5 and 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.
✕. Has a chronic condition requiring the use of systemic corticosteroids \>10 milligram per day (mg/day) of prednisone or equivalent.