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): a doublet therapy built on a FOUNDATION of POMALYST.

MM-003 Trial Design.1,2

POMALYST was studied in a Phase 3, multicenter, randomized, open-label trial of POMALYST + low-dose dex vs high-dose dex in patients with relapsed/refractory multiple myeloma who had received at least 2 prior treatment regimens, including lenalidomide and bortezomib, and demonstrated disease progression on or within 60 days of last therapy (ITT population, N=455). Some key exclusion criteria included serum bilirubin >2.0 mg/dL, AST/ALT >3x ULN, and CrCl <45 mL/min.

Patients in the POMALYST + low-dose dex arm (n=302) received 4 mg of POMALYST orally on Days 1-21 of 28-day cycles with 40 mg of low-dose dex once daily on Days 1, 8, 15, and 22 of 28-day cycles. Patients in the high-dose dex arm (n=153) received 40 mg of dex once daily on Days 1-4, 9-12, and 17-20 of 28-day cycles. Patients >75 years received 20 mg of dex in the same respective dosing schedules. Patients receiving POMALYST + low-dose dex were required to receive prophylaxis or anti-thrombotic treatment, as well as any other patient with a history of DVT or PE. The primary endpoint was PFS, and a key secondary efficacy endpoint was OS. Treatment continued until disease progression.

*Patients >75 years received 20 mg of dex in the same respective schedules.



Refractory to


Refractory to


to both1

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

Patient population background.1

POMALYST® (pomalidomide) + dexamethasone Phase 3 Trial Baseline Characteristics table

Data cutoff: March 1, 2013.

Patients had received a median of 5 prior therapies

  • Median patient age was 64 years (range: 35-87)3
  • 59% of patients were male
  • 78% of patients were White, 1.5% Black or African American, <1% were Asian, and <1% were other race
  • The ECOG performance status was 0 in 32%, 1 in 49%, 2 in 17%, and 3 in <1% of patients; ISS Stage was I-II in 64%, and III in 32% of patients1,2
  • 41% of patients had del13q14, del17p13, t(4;14), or t(14;16)3

ALT, alanine aminotransferase; AST, aspartate transaminase; CrCl, creatinine clearance; dex, dexamethasone; DVT, deep vein thrombosis; ECOG, Eastern Cooperative Oncology Group; ISS, International Staging System; ITT, intent-to-treat; OS, overall survival; Pd, POMALYST + dexamethasone; PE, pulmonary embolism; PFS, progression-free survival; PI, proteasome inhibitor; RRMM, relapsed/refractory multiple myeloma; ULN, upper limit of normal.

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.

POMALYST + low-dose dex was
studied vs high-dose dex.1

See the Trial Data