Recently Diagnosed or Relapsed? Stop Looking For a Miracle Cure, and Use Evidence-Based Therapies To Enhance Your Treatment and Prolong Your Remission
Multiple Myeloma an incurable disease, but I have spent the last 25 years in remission using a blend of conventional oncology and evidence-based nutrition, supplementation, and lifestyle therapies from peer-reviewed studies that your oncologist probably hasn't told you about.
Click the orange button to the right to learn more about what you can start doing today.
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Post ASCT Maintenance- Dara or Rev?
For post-ASCT maintenance, Dara or Rev? Or both Daratumumab and Revlimid? The AURIGA Study compared the standard maintenance therapy of Revlimid (lenalidomide) to Darzalex (daratumumab) plus Revlimid (lenalidomide).
The challenge that lay people face when trying to understand clinical trials is that “the devil is in the details,” as the saying goes. The details that MM patients must understand are:
- There is an increased risk of side effects with Daratumumab plus Revlimid. My interpretation of this finding is that older MMers will be at greater risk of side effects than younger MMers.
- The study looks at MMers ONLY who have completed an ASCT.
- The study looks at MMers ONLY who have not had daratumumab previously. Not a part of their induction therapy.
Maintenance Therapy : Revlimid vs. Revlimid + Dara | AURIGA Update|
Please don’t misunderstand me. I am not saying that Daratumumab plus Revlimid maintenance won’t increase your PFS or deepen the results from your ASCT.
I’m simply saying that your results will probably be less than the AURIGA study findings.
I am a long-term MM survivor and MM cancer coach. If you have questions about your MM, email me at David.PeopleBeatingCancer@gmail.com.
Hang in there,
David Emerson
- MM Survivor
- MM Cancer Coach
- Director Pe9pleBeatingCancer
Daratumumab with lenalidomide as maintenance after transplant in newly diagnosed multiple myeloma: the AURIGA study
Abstract
No randomized trial has directly compared daratumumab and lenalidomide (D-R) maintenance with standard-of-care lenalidomide (R) alone after transplant. Herein, we report the primary results of the phase 3 AURIGA study evaluating D-R vs R maintenance in patients with newly diagnosed multiple myeloma (NDMM) who had very good or better partial response, were minimal residual disease (MRD)-positive (10–5) and anti-CD38–naïve after transplant.
Two hundred patients were randomly assigned (1:1) to D-R (n = 99) or R (n = 101) maintenance for up to 36 cycles. The MRD-negative (10–5) conversion rate by 12 months from start of maintenance (primary end point) was significantly higher for D-R than R (50.5% vs 18.8%; odds ratio [OR], 4.51; 95% confidence interval [CI], 2.37-8.57; P < .0001). MRD-negative (10–6) conversion rate was similarly higher with D-R (23.2% vs 5.0%; OR, 5.97; 95% CI, 2.15-16.58; P = .0002).
At median follow-up (32.3 months), D-R achieved a higher overall MRD-negative (10–5) conversion rate (D-R, 60.6% vs R, 27.7%; OR, 4.12; 95% CI, 2.26-7.52; P < .0001) and complete response rate or better (75.8% vs 61.4%; OR, 2.00; 95% CI, 1.08-3.69; P = .0255) vs R.
Progression-free survival (PFS) favored D-R vs R (hazard ratio, 0.53; 95% CI, 0.29-0.97); estimated 30-month PFS rates were 82.7% for D-R and 66.4% for R. Incidences of grade 3/4 cytopenias (54.2% vs 46.9%) and infections (18.8% vs 13.3%) were slightly higher with D-R than R.
In conclusion, D-R maintenance achieved a higher MRD-negative conversion rate and improved PFS after transplant vs R, with no new safety concerns. This trial was registered at www.clinicaltrials.gov as #NCT03901963…
Efficacy
The primary end point of MRD-negative (10–5) conversion rate from baseline to 12 months of maintenance treatment was achieved in 50 patients (50.5%) in the D-R group and 19 patients (18.8%) in the R group (OR, 4.51; 95% CI, 2.37-8.57; P < .0001) (Figure 2), representing a statistically significant difference…
At a median follow-up of 32.3 months, the overall MRD-negative (10–5) conversion rate was greater for D-R than for R (60.6% [60/99] vs 27.7% [28/101], respectively; OR, 4.12; 95% CI, 2.26-7.52; P < .0001). The rate of sustained MRD negativity lasting ≥6 months for D-R was ∼2.5 times that of R (35.4% [35/99] vs 13.9% [14/101], respectively; OR, 3.40; 95% CI, 1.69-6.83; P = .0005), and D-R had a higher rate of sustained MRD negativity lasting ≥12 months compared with R (17.2% [17/99] vs 5.0% [5/101]; OR, 4.08; 95% CI, 1.43-11.62; P = .0065) (supplemental Table 3)…
Safety
A total of 194 patients (D-R, n = 96; R, n = 98) received ≥1 dose of study treatment and comprised the safety analysis set. Treatment-related AEs of any grade were reported in 99.0% of patients in both treatment groups. Grade 3/4 AEs occurred in 74.0% of patients in the D-R group and 67.3% of patients in the R group…
Serious AEs were reported in 30.2% and 22.4% of D-R and R patients, respectively; the most frequent across both groups was pneumonia (4.2% and 4.1%, respectively).
The proportion of patients with AEs leading to treatment discontinuation of any treatment component was 14.6% in the D-R group and 8.2% in the R group, most commonly due to myelodysplastic syndrome (D-R, 2.1%; R, 1.0%) for D-R and peripheral sensory neuropathy (0; 2.0%) for R…
- Cytopenias of any grade were more common for D-R than for R (75.0% vs 69.4%), including grade 3/4 cytopenias (54.2% vs 46.9%)…
- The overall incidence of grade 3/4 infections in the 2 treatment groups was 18.8% and 13.3% for D-R and R, respectively, with the most common being pneumonia (5.2% vs 4.1%)…
- A complete summary of secondary primary malignancies (SPMs) is provided in supplemental Table 5. A total of 7.3% of patients in the D-R group and 4.1% in the R group had SPMs…
Discussion
In the randomized, phase 3 AURIGA study, the addition of daratumumab to R maintenance resulted in a significantly higher MRD-negative conversion rate among transplant-eligible patients with NDMM who had ≥VGPR, were MRD-positive, and were anti-CD38–naïve after ASCT, compared with R maintenance alone.
This increase in MRD-negative conversion was clinically meaningful given that D-R maintenance trended toward improved PFS, higher overall MRD-negative conversion rates, and deeper responses compared with R maintenance alone, with no unexpected safety concerns…
post ASCT maintenance Dara or Rev post ASCT maintenance Dara or Rev post ASCT maintenance Dara or Rev