The following criteria is provided for health care professionals.
Inclusion Criteria:
Inclusion Criteria Part 1
- With a confirmed diagnosis of MM.
- With RRMM who have failed treatment with, are intolerant to, or are not candidates for available therapies that are known to confer clinical benefit in this participant population.
- Should meet all of the following criteria for prior therapy:
- Should be refractory to at least one proteasome inhibitor (PI), at least one immunomodulatory drug (IMiD), and at least 1 steroid.
- Should either have received >=3 prior lines of therapy or should have received at least two prior lines of therapy if one of those lines included a combination of PI and IMiD.
- Prior treatment with an anti-CD38 therapy (including daratumumab) is permitted.
- With measurable disease, defined as at least 1 of the following:
- Serum M-protein >=500 mg/dL (>=5 g/L) on serum protein electrophoresis (SPEP).
- Urine M-protein >=200 mg/24 h 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.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- With normal QT interval corrected by the Fridericia method (QTcF) on screening electrocardiogram (ECG), defined as QTcF of <=450 millisecond (ms) in males or <=470 ms in females
- Must meet the following clinical laboratory criteria at study entry:
- Total bilirubin <=1.5*the upper limit of the normal range (ULN), except for participant with Gilbert's syndrome, in whom the direct bilirubin must be <2.0*ULN.
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be <=2.5*ULN.
- Estimated glomerular filtration rate (eGFR) >=30 milliliters per minute (mL/min/1.73 square meter [m^2], using the modification of diet in renal disease (MDRD) equation.
- Absolute neutrophil count (ANC) >=1000 per cubic millimeter (/mm^3) (>=1.0*10^ 9 per liter [/L]); a count of >=750/mm^3 (>=0.75*10^ 9/L) may be acceptable for participants with >50% of plasma cells in bone marrow, after discussion with the sponsor.
- Platelet count >=75,000/ mm^3 (>=75*10^ 9/L); a value of >=50,000/ mm^3 (>=50*10^ 9/L) may be acceptable for participants with >50% of plasma cells in bone marrow, after discussion with the sponsor.
- Hemoglobin >=7.5 g/dL (it is not permissible to transfuse a participant to reach this level).
Inclusion Criteria Part 2
- With a confirmed diagnosis of MM.
- Should meet all of the following criteria for prior therapy:
- Should be refractory or intolerant to at least 1 PI and at least 1 IMiD.
- Should either have received >=3 prior lines of therapy or should have received at least 2 prior lines of therapy if 1 of those lines included a combination of PI and IMiD.
- Prior treatment with an anti-CD38 therapy (including daratumumab) is permitted, except for participants enrolled into the anti-CD38-therapy naïve expansion cohort.
- Daratumumab-RR cohorts (once weekly and once every two weeks TAK-169 dosing): Participant must be RR to daratumumab at any time during treatment. Of note, participant's RR to other anti-CD38 therapies are excluded.
- Anti-CD38 Therapy Naïve cohort (once weekly dosing): Participants must not have received any prior anti-CD38 therapy.
- With measurable disease, defined as at least 1 of the following:
- Serum M-protein >=500 mg/dL (>=5 g/L) on SPEP.
- Urine M-protein >=200 mg/24 hours on UPEP.
- Serum FLC assay result with an involved FLC level >=10 mg/d (>=100 mg/L), provided the serum FLC ratio is abnormal
- ECOG performance status score of 0 or 1.
- With normal QTcF on screening ECG, defined as QTcF of <=450 ms in males or <=470 ms in females
- Must meet the following clinical laboratory criteria at study entry:
- Total bilirubin <=1.5*the ULN, except for participant with Gilbert's syndrome, in whom the direct bilirubin must be <2.0*ULN.
- Serum ALT and ASTmust be <=2.5*ULN.
- eGFR >=30 mL/min/1.73 m^2, using the MDRD equation.
- ANC >=1000 mm^3 (>=1.0*10^ 9 /L); a count of >=750/mm^3 (>=0.75*10^ 9/L) may be acceptable for participant with >50% of plasma cells in bone marrow, after discussion with the sponsor.
- Platelet count >=75,000/ mm^3 (>=75*10^ 9/L); a value of >=50,000/ mm^3 (>=50*10^ 9/L) may be acceptable for participants with >50% of plasma cells in bone marrow, after discussion with the sponsor.
- Hemoglobin >=7.5 g/dL (it is not permissible to transfuse a participant to reach this level).
Exclusion Criteria:
- With polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, or Immunoglobulin M (IgM) myeloma.
- With sensory or motor neuropathy of NCI CTCAE Grade >=3.
- Have received a final dose of any of the following treatments/procedures within the following minimum interval before the first dose of TAK-169:
- Myeloma-specific therapy, including PIs and IMiDs-14 days
- Anti-CD38 (a) therapy (Once the MTD/RP2D has been established, the washout period may be adjusted in the expansion phase (Part 2) of the study for participants who have received anti-CD38 therapy )-90 days
- Corticosteroid therapy for myeloma- 7 days
- Radiation therapy for localized bone lesions- 14 days
- Major surgery-30 days
- Autologous stem cell transplant- 90 days
- Investigational therapy- 30 days
- Have received an allogeneic stem cell transplant or organ transplantation.
- Have not recovered, to NCI CTCAE V5 Grade <=1 or baseline, from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) excluding alopecia.
- With clinical signs of central nervous system (CNS) involvement of MM.
- With known or suspected light chain amyloidosis of any organ (the presence of amyloid on the bone marrow biopsy without other evidence of amyloidosis is acceptable).
- With congestive heart failure (New York Heart Association) class >=II or left ventricular ejection fraction (LVEF <40%, cardiac myopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris or myocardial infarction within the past 6 months, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension.
- With chronic or active infection requiring systemic therapy, as well as a history of symptomatic viral infection that has not been fully cured (example, human immunodeficiency viruses (HIV) or viral hepatitis B or C).
- With a history of systemic inflammatory response syndrome (SIRS)/ cytokine release syndrome (CRS) reactions following infusion with any monoclonal antibodies or Chimeric Antigen Receptor (CAR) T-cell therapy
- With a chronic condition requiring the use of systemic corticosteroids at a dose of >10 milligram per day (mg/day) of prednisone or equivalent.