E-resources
Peer reviewed
Open access
-
Delimpasi, Sosana; Dimopoulos, Meletios A.; Straub, Jan; Symeonidis, Argiris; Pour, Luděk; Hájek, Roman; Touzeau, Cyrille; Bhanderi, Viralkumar K.; Berdeja, Jesus G.; Pavlíček, Petr; Matous, Jeffrey V.; Robak, Pawel J.; Suryanarayan, Kaveri; Miller, Alison; Villarreal, Miguel; Cherepanov, Dasha; Srimani, Jaydeep K.; Yao, Huilan; Labotka, Richard; Orlowski, Robert Z.
American journal of hematology, 06/2024Journal Article
Abstract Novel therapies have improved outcomes for multiple myeloma (MM) patients, but most ultimately relapse, making treatment decisions for relapsed/refractory MM (RRMM) patients increasingly challenging. We report the final analysis of a single‐arm, phase 2 study evaluating the oral proteasome inhibitor (PI) ixazomib combined with daratumumab and dexamethasone (IDd; NCT03439293). Sixty‐one RRMM patients (ixazomib/daratumumab‐naïve; 1–3 prior therapies) were enrolled to receive IDd (28‐day cycles) until disease progression/unacceptable toxicity. Median age was 69 years; 14.8% of patients had International Staging System stage III disease; 14.8% had received three prior therapies. Patients received a median of 16 cycles of IDd. In 59 response‐evaluable patients, the overall response rate was 64.4%; the confirmed ≥very good partial response (VGPR) rate (primary endpoint) was 30.5%. Rates of ≥VGPR in patient subgroups were: high‐risk cytogenetics ( n = 15, 26.7%), expanded high‐risk cytogenetics ( n = 24, 29.2%), aged ≥75 years ( n = 12, 16.7%), lenalidomide‐refractory ( n = 21, 28.6%), and prior PI/IMiD therapy ( n = 58, 31.0%). With a median follow‐up of 31.6 months, median progression‐free survival was 16.8 months (95% confidence interval: 10.1–23.7). Grade ≥3 treatment‐emergent adverse events (TEAEs) occurred in 54.1% of patients; 44.3% had serious TEAEs; TEAEs led to dose modifications/reductions/discontinuations in 62.3%/36.1%/16.4%. There were five on‐study deaths. Any‐grade and grade ≥3 peripheral neuropathy occurred in 18.0% and 1.6% of patients. Quality of life was generally maintained throughout treatment. IDd showed a positive risk‐benefit profile in RRMM patients and was active in clinically relevant subgroups with no new safety signals.
Author
Shelf entry
Permalink
- URL:
Impact factor
Access to the JCR database is permitted only to users from Slovenia. Your current IP address is not on the list of IP addresses with access permission, and authentication with the relevant AAI accout is required.
Year | Impact factor | Edition | Category | Classification | ||||
---|---|---|---|---|---|---|---|---|
JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
Select the library membership card:
If the library membership card is not in the list,
add a new one.
DRS, in which the journal is indexed
Database name | Field | Year |
---|
Links to authors' personal bibliographies | Links to information on researchers in the SICRIS system |
---|
Source: Personal bibliographies
and: SICRIS
The material is available in full text. If you wish to order the material anyway, click the Continue button.