Table 2 Primary end-point, main inclusion criteria and estimated enrollment of ongoing phase 3 trials that include patients progressing on lenalidomide
From: Treatment of patients with multiple myeloma progressing on frontline-therapy with lenalidomide
CANDOR (NCT03158688): |
Objective: |
-To compare Kd, and Daratumumab-Kd in terms of PFS in patients with MM who have relapsed after 1 to 3 prior therapies. |
Main inclusion criteria: |
-Relapsed or progressive MM after last treatment |
-Received at least 1, but not more than 3 prior lines of therapy for MM |
Estimated enrollment: 466 patients |
IKEMA (NCT03275285): |
Objective: |
-To compare Kd, and Isatuximab-Kd in terms of PFS in patients with MM who have relapsed after 1 to 3 prior therapies. |
Main inclusion criteria: |
-Patients with MM previously treated with prior 1 to 3 lines |
Estimated enrollment: 300 patients |
ICARIA (NCT 02990338): |
Objective: |
-To compare Pom-dex, and Isatuximab-Pom-dex in terms of PFS in patients with RRMM |
Main inclusion criteria: |
-Patients must have received at least 2 prior lines of anti-myeloma therapy |
-Patients must have failed treatment with lenalidomide and a proteasome inhibitor |
-Patients must have progressed on or within 60 days after end of previous therapy before study entry, i.e., refractory to the last line of treatment |
Estimated enrollment: 300 patients |
APPOLLO / EMN14 (NCT 03180736): |
Objective: |
-To compare Pom-dex, and Daratumumab-Pom-dex in terms of PFS in patients with RRMM |
Main inclusion criteria: |
-Subjects must have received prior anti-myeloma treatment. The prior treatment must have included both a PI- and lenalidomide-containing regimen. The subject must have had a response to prior therapy |
-Subjects must have documented evidence of PD on or after the last regimen |
-Subjects who received only 1 line of prior treatment must have demonstrated PD on or within 60 days of completion of the lenalidomide-containing regimen |
Estimated enrollment: 302 patients |
BOSTON (NCT03110562): |
Objective: |
-To compare Vd, and Vd-Selinexor in terms of PFS in patients with RRMM |
Main inclusion criteria |
-Patients must have received at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens |
-Documented evidence of progressive MM on or after their most recent regimen |
Estimated enrollment: 364 patients |
BELLINI (NCT02755597): |
Objective: |
-To compare Vd-placebo, and Vd-Venetoclax in terms of PFS in patients with RRMM |
Main inclusion criteria |
-Participant has documented relapsed or progressive MM on or after any regimen, or refractory to the most recent line of therapy |
-Participant must have received prior treatment with at least one, but no more than three prior lines of therapy for MM |
Estimated enrollment: 291 patients |