REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of adult patients with multiple myeloma (MM). REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT). REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.
REVLIMID in combination with daratumumab and dexamethasone (DRd)
An FDA-approved triplet with REVLIMID
for patients with NSCT NDMM.2,10
Watch Dr. Faith Davies share her thoughts on the DRd regimen for patients with NDMM ineligible for stem cell transplant.
MAIA was a Phase 3, open-label, randomized, multicenter trial of DRd (n=368) vs Rd (n=369) in adult patients with NDMM who were ineligible for an auto-SCT.1
Indication for REVLIMID + dexamethasone + daratumumab (DRd)
DRd is indicated for the treatment of adult patients with newly diagnosed MM who are ineligible for an autologous stem cell transplant.
Information about DRd does not appear in the REVLIMID full Prescribing Information. Please see the daratumumab full Prescribing Information and Important Safety Information at www.darzalex.com.
An expert perspective.
Dr. Faith Davies—a multiple myeloma specialist—discusses why she considers DRd an effective and viable treatment option for appropriate patients with NDMM not eligible for a stem cell transplant.
44% reduction in the risk of disease progression or death with DRd.1,2
MEDIAN PFS

DRd and Rd were continued until disease
progression or unacceptable toxicity.1
PFS was defined as the time from randomization to either disease progression or death.
The primary endpoint was PFS according to IMWG criteria.
Selected Safety Information.
Contraindications for daratumumab: Daratumumab is contraindicated in patients with a history of severe hypersensitivity (eg, anaphylactic reactions) to daratumumab or any of the components of the formulation.
WARNINGS AND PRECAUTIONS FOR DARATUMUMAB
- Infusion-related reactions: Interrupt daratumumab infusion for infusion-related reactions of any severity. Permanently discontinue the infusion in case of anaphylactic reactions or life-threatening infusion reactions and institute appropriate emergency care.
- Interference with cross-matching and red blood cell antibody screening: Type and screen patients prior to starting treatment. Inform blood banks that a patient has received daratumumab.
- Neutropenia: Monitor complete blood cell counts periodically during treatment. Consider withholding daratumumab until recovery of neutrophils.
- Thrombocytopenia: Monitor complete blood cell counts periodically during treatment. Consider withholding daratumumab until recovery of platelets.
- Interference with determination of complete response: Daratumumab can interfere with the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
- Embryo-Fetal Toxicity: Can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception.
48% of patients achieved ≥CR with DRd.1
RESPONSE AND MRD-NEGATIVE RATES

- ≥CR = CR + sCR
- DRd ORR = sCR (30.4%) + CR (17.1%) + VGPR (31.8%) + PR (13.6%)
- Rd ORR = sCR (12.5%) + CR (12.5%) + VGPR (28.2%) + PR (28.2%)
- MRD was measured by next-generation sequencing (NGS) to 10-5
DRd and Rd were continued until disease
progression or unacceptable toxicity.1
MAIA STUDY DESIGN (N-737)1,2

MAIA was a Phase 3, open-label, randomized, multicenter trial of DRd (n=368) vs Rd (n=369) in adult patients with NDMM who were ineligible for auto-SCT. Patients were stratified by ISS stage, region, and age (<75 vs ≥75 years). The primary endpoint was PFS according to IMWG criteria. Secondary endpoints included ORR (PR, VGPR, CR, sCR), MRD, and safety, among others. The original protocol provided Rd dosing in the DRd arm for a maximum of 2 years. Dex was continued as a premedication for dara administration even after Rd treatment was discontinued.
The MAIA trial protocol was amended to continue REVLIMID in the DRd arm until disease progression or unacceptable toxicity.1,2
Dose adjustments due to toxicity for REVLIMID and dexamethasone were applied according to the REVLIMID Prescribing Information.
*The starting dose of REVLIMID was adjusted for patients with renal impairment.
†Or reduced dose of 20 mg/week for patients >75 years or BMI <18.5. On daratumumab infusion days, the dexamethasone dose was given as a pre-infusion medication.
PFS was defined as the time from randomization to either disease progression or death.
auto-SCT, autologous stem cell transplantation; BMI, body mass index; CR, complete response; DRd, daratumumab + REVLIMID + dexamethasone; IMWG, International Working Group; MM, multiple myeloma; MRD, median residual response; NDMM, newly diagnosed multiple myeloma; ORR, overall response rate; PFS, progression-free survival; PR, partial response; Rd, REVLIMID + dexamethasone; sCR, stringent complete response; VGPR, very good partial response.
References: 1. Daratumumab [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2019. 2. Facon T, Kumar S, Plesner T, et al. Phase 3 randomized study of daratumumab plus lenalidomide and dexamethasone (Rd) in patients with newly diagnosed multiple myeloma (NDMM) ineligible for transplant (MAIA). Presented at: 60th ASH Annual Meeting and Exposition; December 4, 2018; San Diego, CA.