PHASE 3 TRIAL
TOURMALINE‑MM1 — the first global, phase III, double‑blind, placebo-controlled study investigating an oral PI in RRMM patients1
TOURMALINE‑MM1 enrolled a broad group of RRMM patients who were treated to progression1
The trial compared NINLARO + Rd as part of an all-oral regimen versus placebo + Rd in 722 RRMM patients treated with 1-3 prior therapies1,2
* Stratification: 1 vs 2 or 3 prior therapies; PI exposed vs PI naive; and International Staging System (ISS) stage I or II vs III1,2
† Defined as patients with del(17p), t(4;14) or t(14;16)1
Oral NINLARO was studied in a broad group of RRMM patients, including patients with high‑risk cytogenetics and mild-to-moderate renal impairment1,2
- Clinical laboratory evaluations for high‑risk cytogenetic markers, including del(17p), t(4;14) and t(14;16) were performed by a central laboratory. Positivity for del(17p) was defined by a percentage of positive cells that were above the technical background cut-off of 5%1
Key inclusion criteria:1
Measurable disease by at least one of:
- Serum or urine protein electrophoresis
- Free light chain assay
Relapsed and/or refractory disease:*
- Including primary refractory patients (no response to all therapies)
- Patients who had received 1-3 prior treatments
Creatinine clearance ≥30 mL/min
Key exclusion criteria:
Refractory to previous PI-based or lenalidomide-based treatment
*Refractory = progression of disease on treatment or within 60 days after last dose of therapy
- Moreau P, Masszi T, Grzasko N. N Engl J Med. 2016;374:1621-34.
- NINLARO (ixazomib capsules) Summary of Product Characteristics.
- Takeda Data on File UK/DF/1903/0005.