A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Nov 30, 2022
  • participants needed
    460
  • sponsor
    Amgen
Updated on 24 November 2020
Investigator
Amgen Call Center
Primary Contact
Research Site (1.3 mi away) Contact
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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.

Details
Treatment Dexamethasone, Lenalidomide, Carfilzomib
Clinical Study IdentifierNCT03859427
SponsorAmgen
Last Modified on24 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 99 yrs?
Gender: Male or Female
Do you have Relapsed or Refractory Multiple Myeloma?
Do you have any of these conditions: Do you have Relapsed or Refractory Multiple Myeloma??
Do you have any of these conditions: Do you have Relapsed or Refractory Multiple Myeloma??
Documented relapse or progressive multiple myeloma after last treatment
Subjects refractory to the most recent line of therapy are eligible, unless
last treatment contained PI or lenalidomide and dexamethasone). Refractory is
defined as disease that is nonresponsive or progresses within 60 days of last
therapy
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 or the combination of lenalidomide and dexamethasone
are allowed, if, the patient had at least a PR to the most recent therapy with
a PI or lenalidomide and dexamethasone, neither PI or lenalidomide and
dexamethasone in combination were ceased due to toxicity (unless at the time
of enrollment that toxicity was neuropathy not exceeding grade 2 which has
either resolved or if ongoing is less than or equal to grade 1), the patient
has not received a PI and has not received lenalidomide and dexamethasone in
combination in the 6 months prior to first study treatment. (Patients are
permitted to have received single agent lenalidomide as maintenance therapy
during the 6 months prior to first treatment)
Previous treatment with a lenalidomide and dexamethasone containing regimen is
allowed, as long as the subject did not progress during the first 3 months
after initiating lenalidomide and dexamethasone containing therapy
Measurable disease with at least 1 of the following assessed within 21 days
prior to
randomization
Inmunoglobulin G (IgG) multiple myeloma: serum monoclonal protein (M-protein) level 1.0 g/dL
Inmunoglobulin A (IgA), Inmunoglobulin D (IgD), Inmunoglobulin E (IgE) multiple myeloma: serum M-protein level 0.5 g/dL
Urine M-protein 200 mg per 24 hours
In subjects without measurable serum or urine M-protein, serum-free light chain (SFLC) 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 2
Other inclusion criteria may apply

Exclusion Criteria

Waldenstrm macroglobulinemia
Multiple myeloma of Inmunoglobulin M (IgM) subtype
Plasma cell leukemia (> 2.0 10^9 /L circulating plasma cells by standard
differential)
Uncontrolled hypertension, defined as a subject whose blood pressure exceeds
mmHg systolic or 100 mmHg diastolic when taken in accordance with the
European Society of Hypertension/European Society of Cardiology 2018
guidelines
Active congestive heart failure (New York Heart Association Class III to IV)
symptomatic ischemia, uncontrolled arrhythmias, screening ECG with corrected
QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction
within 4 months prior to randomization
Calculated or measured creatinine clearance < 1.0 mL/s (calculation must be
based on the Cockcroft and Gault formula) within 21 days prior to
randomization
Other exclusion criteria may apply
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