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



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.

SparkCures ID 1011
Trial Phase Phase 3
Enrollment 460 Patients
Trial Sponsors
  • Amgen
NCT Identifier


Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

Documented relapse or progressive multiple myeloma on or after any treatment (subjects refractory to the most recent line of therapy are eligible, unless last treatment contained PI or lenalidomide and dexamethasone).

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, 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:

Waldenström 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 an average systolic blood pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg despite optimal treatment (blood pressure to be measured following European Society of Hypertension/European Society of Cardiology 2013 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

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Oncology Hematology Care, Inc.

Blue Ash, OH

Texas Oncology (Fort Worth)

Fort Worth, TX

Texas Oncology The Woodlands

The Woodlands, TX

Oncology Hematology Care, Inc.

Blue Ash, OH

Texas Oncology (Fort Worth)

Fort Worth, TX

Texas Oncology The Woodlands

The Woodlands, TX

International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please be aware that the government website may include information that is inaccurate and/or out-of-date.


There are no resources, links or videos to display for this clinical trial.

Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message