The purpose of this study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when
administered to participants with NDMM in combination with the backbone treatment regimen.
The drug being tested in this study is called TAK-079. TAK-079 is being tested to evaluate
the safety, tolerability, efficacy, and pharmacokinetic (PK) when added to 1 of 2 standard
backbone regimens (LenDex or VRd) with newly diagnosed NDMM for whom stem cell
transplantation (SCT) is not planned as initial therapy.
The study will enroll approximately 36 participants. Participants will be non-randomly
assigned to one of the two treatment groups:
- TAK-079 and LenDex
- TAK-079 and VRd
This multi-center trial will be conducted in the United States. The overall time to
participate in this study is 36 months. Participants will have a follow-up visit 30 days
after the last dose of study drug or before the start of subsequent alternative anticancer
therapy, to permit the detection of any delayed AEs.
1. Must have previously untreated multiple myeloma (MM) as defined by the IMWG criteria
requiring treatment according to the investigator.
2. Are appropriate candidates for either the VRd or Rd backbone antimyeloma therapy
according to the investigator.
3. Must have measurable disease defined by at least 1 of the following:
- Serum M-protein >=1 gram per deciliter (g/dL) (>=10 gram/liter [g/L]).
- Urine M-protein >=200 mg/24 h.
- Serum FLC assay: involved FLC level >=10 mg/dL (≥100 milligram per liter [mg/L])
provided the serum FLC ratio is abnormal.
4. Participants receiving lenalidomide must be able to take concurrent prophylactic
anticoagulation per standard clinical practice as directed by the investigator.
5. Life expectancy >3 months.
6. Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal
to (<=) 2.
1. Prior systemic therapy for MM.
o treatment with bisphosphonates or a single course of glucocorticoids does not
disqualify the participant (the maximum dose of corticosteroids should not exceed the
equivalent of 160 mg [for example, 40 milligram per day (mg/d) for 4 days] of
2. Current participation in another interventional study, including other clinical trials
with investigational agents (including investigational vaccines or investigational
medical device) within 4 weeks of the first dose of TAK-079 or any agent in the
backbone regimen and throughout the duration of this trial.
3. Prior radiation therapy within 14 days of the first dose of TAK-079 or any backbone
NOTE: Prophylactic localized ("spot") radiation for areas of pain is allowed.
4. Major surgery within 4 weeks before Cycle 1 Day 1 (kyphoplasty is not considered major
surgery). Participants should be fully recovered from any surgically related
5. Plasmapheresis within 28 days of randomization.
6. If plasmacytoma is the only measurable parameter for assessing disease response,
participant is not eligible because of difficult response evaluation.
7. Clinical signs of meningeal involvement of MM exhibited during screening.
8. Serum positive for human immunodeficiency virus (HIV) or active hepatitis B virus
(HBV) or hepatitis C virus (HCV) infection.
9. Known severe allergic or anaphylactic reactions to human recombinant proteins or
excipients used in the TAK-079 formulation or agents in the backbone regimen
(lenalidomide, bortezomib, dexamethasone) as per the respective prescribing
information or for TAK-079, as outlined in the current investigator's brochure (IB).
10. Systemic infection requiring systemic antibiotic therapy or other serious infection
within 14 days before the first dose of TAK-079 or any agent in the backbone regimen.
Urinary tract infection is not considered a systemic infection.
11. A 12-lead electrocardiogram (ECG) showing a QT interval corrected by Frederica's
formula (QTcF) >470 milliseconds. If a machine reading is above this value, the ECG
should be reviewed by a qualified reader and confirmed on a subsequent ECG.
12. Diagnosis of primary amyloidosis, Waldenstrom's disease, monoclonal gammopathy of
undetermined significance (MGUS) or smoldering multiple myeloma (SMM) per IMWG
criteria or standard diagnostic criteria, plasma cell leukemia (according to the World
Health Organization [WHO] criterion: >=20% of cells in the peripheral blood with an
absolute plasma cell count of more than 2 *10^9/L), polyneuropathy, organomegaly,
endocrinopathy, monoclonal gammopathy and skin changes (POEMS syndrome),
myelodysplastic syndrome, or myeloproliferative syndrome.
13. History of myelodysplastic syndrome or another malignancy other than MM, except for
the following: any malignancy that has been in complete remission for 2 years,
adequately treated local basal cell or squamous cell carcinoma of the skin, cervical
carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer (Gleason
score <=6 without known metastatic disease and with no requirement for therapy, or
requiring only hormonal therapy and stable prostate-specific antigen for >=1 year
before initiation of study therapy), breast carcinoma in situ with full surgical
resection, and treated medullary or papillary thyroid cancer.