At a glance
ClinicalIndex Comparison Record- ✓Relapsed or refractory multiple myeloma with documented relapse or progression after most recent treatment
- ✓At least 1–3 prior lines of therapy for multiple myeloma (stem cell transplant with consolidation/maintenance counts as 1 line)
- ✓At least partial response (PR) to at least 1 prior line of therapy
- ✓Measurable disease: serum M-protein ≥1.0 g/dL (IgG), ≥0.5 g/dL (IgA/D/E), urine M-protein ≥200 mg/24h, or SFLC ≥100 mg/L with abnormal ratio
- ✕Waldenström macroglobulinemia or IgM subtype multiple myeloma
- ✕Plasma cell leukemia with >2.0 × 10^9/L circulating plasma cells
- ✕Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg)
- ✕Active congestive heart failure (NYHA Class III–IV), symptomatic ischemia, uncontrolled arrhythmias, QTc >470 msec, pericardial disease, or myocardial infarction within 4 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)
In Brief
A Phase 3 clinical trial evaluating Carfilzomib, Lenalidomide, and 1 other intervention for Relapsed or Refractory Multiple Myeloma. Completed, enrolled 454 participants across 108 sites in 17 countries.
Detailed Summary
Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy.
Study Details
Timeline
Interventions
Once weekly IV over 30 minutes on day 1, 8 and 15 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 day 1 and 56 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.
Twice weekly IV over 10 minutes on day 1, 2, 8, 9, 15 and 16 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 days 1 and 2 and 27 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.
Once daily orally 25 mg days 1 to 21 of each cycle. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent
Once daily orally or by IV 40 mg days 1, 8 and 15 of each cycle. Also day 22 of cycles 1 to 9. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent