x POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

See other indications for POMALYST:

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POMALYST® (pomalidomide) + dex (Pd)

Proven overall survival benefit vs high-dose dex.1,2

(Secondary endpoint)


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Reduced risk of death vs high-dose dex

Median OS: 12.4 months (95% CI 10.4, 15.3) vs 8.0 months (95% CI 6.9, 9.0) (HR 0.70; 95% CI 0.54, 0.92; P=0.009)

Data cutoff: March 1, 2013.

Pd improved median overall survival vs high-dose dex in the doublet Phase 3 trial.1

In the Phase 3 trial, OS was based on the assessment by the Independent Review Adjudication Committee (IRAC) review at the final OS analysis.1

POMALYST + low-dose dex doubled the median progression-free survival of high-dose dex (primary endpoint).1

  • Median PFS was significantly longer with POMALYST + low-dose dex vs high-dose dex (3.6 vs 1.8 months; HR 0.45; 95% Cl 0.35, 0.59; P<0.001)

In the Phase 3 trial, PFS was based on the assessment by the IRAC review at the final PFS analysis.1

OS subgroup analysis included Pd immediately after REVLIMID® (lenalidomide).3*

Analysis limitations

  • These exploratory analyses should not be interpreted to determine a treatment difference between arms in these select subgroups because of potential selection bias, insufficient sample size, and a higher probability of making a false-positive finding

*Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.

CI, confidence interval; dex, dexamethasone; HR, hazard ratio; IRAC, Independent Review Adjudication Committee; ITT, intent-to-treat; OS, overall survival; Pd, POMALYST + dexamethasone; PFS, progression-free survival.

References: 1. POMALYST [package insert]. Summit, NJ: Celgene Corp. 2. San Miguel J, Weisel K, Moreau P, et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomized, open-label, phase 3 trial. Lancet Oncol. 2013;14(11)1055-1066. 3. Data on file. Bristol-Myers Squibb Co; 2018.

Pd has a well-established safety profile.1

View Safety