Discover how the NINLARO® (ixazomib) regimen* real-world evidence (RWE) can complement clinical trial results1-5

*The NINLARO regimen included NINLARO+lenalidomide+dexamethasone.1

RWE PROVIDES DATA ABOUT PATIENT OUTCOMES FROM ROUTINE CLINICAL PRACTICE

Randomized, controlled trials (RCTs) are the gold standard for measuring efficacy and safety, however:

  • Up to 72% of real-world patients with relapsed and/or refractory multiple myeloma (RRMM) do not meet eligibility criteria for clinical trials6
  • Real-world studies include a broader range of patients with RRMM who are underrepresented in clinical trials3,7

Receiving routine care in the United States.6

THE TOURMALINE-MM1 PIVOTAL TRIAL EVALUATED EFFICACY AND SAFETY FOR THE NINLARO REGIMEN*

TOURMALINE-MM1 was a global, phase 3, randomized, double-blind, placebo-controlled clinical trial that evaluated the efficacy and safety of NINLARO+lenalidomide+dexamethasone vs placebo+lenalidomide+dexamethasone in patients with RRMM who had received at least one prior line therapy (N=722).1,2 Explore MM1 efficacy Explore MM1 safety

*The NINLARO regimen included NINLARO+lenalidomide+dexamethasone.1

CONSISTENT EFFICACY AND SAFETY WERE DEMONSTRATED WITH THE NINLARO REGIMEN* IN 3 REAL-WORLD STUDIES1-5

Real-world study designs3-5

Terpos et al: A multicenter, retrospective analysis of NINLARO+Rd in relapsed or refractory multiple myeloma. Patients received a median of 1 prior therapy, the same as the TOURMALINE-MM1 study.

Hájek et al: A global retrospective analysis of NINLARO+Rd in patients with relapsed or refractory multiple myeloma who had received a median of 2 prior therapies vs a median of 1 prior therapy in the TOURMALINE-MM1 study.

Minařik et al: A prospective analysis of NINLARO+Rd vs Rd in relapsed or refractory multiple myeloma. Patients received a median of 1 prior therapy, the same as the TOURMALINE-MM1 study.

Consistent PFS was seen with the NINLARO regimen* in the real
world1-5

Discover results from 3 different real-world studies that evaluated RRMM patients outside of clinical trials.

ARs seen in real-world settings were consistent with the known safety profile4,5,8,9

The NINLARO regimen* demonstrated a safety profile comparable to the NINLARO arm in TOURMALINE-MM1 for patients with relapsed/refractory multiple myeloma.1-5

*The NINLARO regimen included NINLARO+lenalidomide+dexamethasone.1
ARs=adverse reactions; PFS=median progression-free survival; Rd=lenalidomide+dexamethasone.

  • Cross-trial comparisons are potentially confounded by differences in trial design and study population. Observational, retrospective analyses are not intended for direct comparison with clinical trials.

REAL-WORLD STUDY LIMITATIONS

Real-world analyses are often nonrandomized, observational, retrospective studies that may have unobserved treatment-selection biases as well as other limitations that should be considered when comparing results with clinical trials. Outcomes should be interpreted with caution because of small sample size, limited follow-up, and limited maturity of data.4 Learn more about study limitations