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)

Phase 3

Completed

Conditions: bloedcel kanker
A form of bone marrow cancer
cancer of plasma cells

Registration Number: NL-OMON52761

Lead Sponsor: Amgen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 2

Inclusion Criteria

• Subject has multiple myeloma with documented relapse or progression after
most recent myeloma treatment.
• Subjects must have at least PR to at least 1 line of prior therapy
• Subjects must have received at least 1 but not more than 3 prior lines of
therapy for multiple myeloma (induction therapy followed by stem cell
transplant and consolidation maintenance therapy will be considered as 1 line
of therapy).
• Prior therapy with a PI is allowed if the patient achieved at least a
PR to most recent treatment with a PI, did not relapse within 60 days of
discontinuation of the PI and the PI was not removed due to toxicity. A
history of prior neuropathy is permitted if this was not grade 3, grade 4 or
grade 2 with pain and if not resolved within the 14 days before enrollment, is
less than or equal to grade 2 without pain.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of < 2

Please refer to section 6.1 of the protocol.

Exclusion Criteria

• Waldenström macroglobulinemia
• Multiple myeloma of IgM subtype
• Active congestive heart failure (New York Heart Association [NYHA] Class III
to IV), symptomatic ischemia, uncontrolled arrhythmias, ECG abnormalities,
pericardial disease, or myocardial infarction within 4 months prior to
enrollment
• Uncontrolled hypertension

Please refer to section 6.2 of the protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>overall response, defined as the best overall response of stringent complete<br /><br>response [sCR], complete response [CR], very good partial response [VGPR], and<br /><br>partial response [PR] per International Myeloma Working Group Uniform Response<br /><br>Criteria [IMWG-URC]) over the duration of the study</p><br>

Secondary Outcome Measures