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.
POMALYST® (pomalidomide) + dex +
EMPLICITI® (elotuzumab):
An approved triplet with POMALYST.1
EMPLICITI is for injection for intravenous use and is available in 300 mg and 400 mg vials.
For adult patients with RRMM who had received
REVLIMID® (lenalidomide)* and a PI.
Trial Design.1-3
POMALYST + dex + EMPLICITI was studied in a Phase 2, randomized, open-label study in patients with RRMM who have received at least 2 prior lines of therapy, including REVLIMID and a PI, and were refractory to the most recent therapy (n=117). Some key exclusion criteria included CrCl <45 mL/min and bilirubin ≥2x ULN or AST/ALT ≥3x ULN. Patients were randomized to receive either POMALYST + dex + EMPLICITI (n=60) or POMALYST + dex (n=57). In the triplet arm, patients received 4 mg of POMALYST orally once daily on Days 1-21 of a repeated 28-day cycle. In Cycles 1 and 2, patients received 10 mg/kg of EMPLICITI IV weekly and dex weekly. From Cycle 3 onward, patients received EMPLICITI 20 mg/kg IV every 4 weeks and dex weekly. In the doublet arm, patients received POMALYST + 40 mg of dex weekly, taken orally (20 mg in patients ≥75 years of age). The primary endpoint was PFS, and a secondary endpoint was ORR.

On days that EMPLICITI was administered, dex 28 mg was given orally between 3 and 24 hours before EMPLICITI plus 8 mg IV between 45 and 90 minutes before EMPLICITI. For patients >75 years, an oral dose of 8 mg and an IV dose of 8 mg were administered. Premedication with dex, H1 blocker diphenhydramine (25-50 mg orally or IV) or equivalent, H2 blocker and 650-1000 mg oral acetaminophen prior to EMPLICITI infusion was required. On weeks without an EMPLICITI infusion, dex was given as an oral, 40-mg dose (20 mg in patients >75 years).
- *Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.
- On weeks with EMPLICITI infusion, dex was given on a divided dose (28 mg oral, 8 intravenous). For patients >75 years, an oral dose of 8 mg was administered.
- On weeks without an EMPLICITI infusion and in the POMALYST + dex arm, dex was given an oral, 40 mg dose (20 mg in patients >75 years).
Important Safety Information for POMALYST and EMPLICITI
POMALYST Boxed WARNINGS
WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM
Embryo-Fetal Toxicity
- POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting POMALYST treatment.
- Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping POMALYST treatment.
POMALYST is only available through a restricted distribution program called POMALYST REMS®.
Venous and Arterial Thromboembolism
- Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with POMALYST. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors.
CONTRAINDICATIONS FOR POMALYST
- Pregnancy: POMALYST can cause fetal harm and is contraindicated in females who are pregnant. If POMALYST is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.
- Hypersensitivity: POMALYST is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide or any of the excipients.
WARNINGS AND PRECAUTIONS
- Embryo-Fetal Toxicity & Females of Reproductive Potential: See Boxed WARNINGS for POMALYST:
- Males: Pomalidomide is present in the semen of patients receiving the drug. Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 4 weeks after discontinuing POMALYST, even if they have undergone a successful vasectomy. Males must not donate sperm.
- Blood Donation: Patients must not donate blood during treatment with POMALYST and for 4 weeks following discontinuation of POMALYST therapy because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST.
- POMALYST REMS Program: See Boxed WARNINGS:
- Prescribers and pharmacies must be certified with the POMALYST REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive POMALYST. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.
- Further information about the POMALYST REMS program is available at www.CelgeneRiskManagement.com or by telephone at 1-888-423-5436.
- Venous and Arterial Thromboembolism: See Boxed WARNINGS for POMALYST: Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors.
- Increased Mortality With Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.