Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma.

Completed · Phase 3

Conditions studied: Relapsed Multiple Myeloma, Refractory Multiple Myeloma

In brief

Compare carfizomib, dexamethasone, and daratumumab (KdD) to Carfilzomib and dexamethasone (Kd) in terms of progression free survival (PFS) in participants with multiple myeloma who have relapsed after 1 to 3 prior therapies.

Key facts

Study ID

NCT03158688

Run by

Amgen

People needed

466

Starts

2017-06-13

Expected to finish

2022-04-15

Last updated by the study team

2025-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Criteria 1 Relapsed or progressive multiple myeloma after last treatment
• Criteria 2 Males or females ≥ 18 years of age
• Criteria 3 Measurable disease with at least 1 of the following assessed within 21 days prior to randomization:
• IgG multiple myeloma: serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dL,
• IgA, IgD, IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL,
• urine M-protein ≥ 200 mg/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
• Criteria 4 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
• Criteria 5 Prior therapy with carfilzomib is allowed as long as the patient had at least a partial response (PR) to most recent therapy with carfilzomib, was not removed due to toxicity, did not relapse within 60 days from discontinuation of carfilzomib, and will have at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not proteasome inhibitors or CD38 antibodies during this 6-month carfilzomib treatment free interval)
• Criteria 6 Prior therapy with anti-CD38 antibodies is allowed as long as the patient had at least a PR to most recent therapy with CD38 antibody, was not removed due to toxicity, did not relapse within 60 days from intensive treatment (at least every other week) of CD38 antibody therapy, and will have at least a 6 month CD38 antibody treatment-free interval from last dose received until first study treatment
• Other inclusion criteria may apply

You may not qualify if…

• Criteria 1 Waldenström macroglobulinemia
• Criteria 2 Multiple myeloma of IgM subtype
• Criteria 3 POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Criteria 4 Plasma cell leukemia (> 2.0 * 10\^9/L circulating plasma cells by standard differential)
• Criteria 5 Myelodysplastic syndrome
• Criteria 6 Known moderate or severe persistent asthma within the past 2 years
• Criteria 7 Known chronic obstructive pulmonary disease (COPD) with a FEV1 < 50% of predicted normal
• Criteria 8 Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction within 4 months prior to randomization
• Other exclusion criteria may apply

Where it is running

• Emory University Winship Cancer Institute — Atlanta, Georgia, United States
• University of Chicago Medical Center - Multiple Myeloma Research Consortium — Chicago, Illinois, United States
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
• Hattiesburg Clinic Hematology/Oncology — Hattiesburg, Mississippi, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• New York Presbyterian Hospital, Weill Cornell Medical College — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Gabrail Cancer Center, LLC — Dover, Ohio, United States
• Charleston Oncology — Charleston, South Carolina, United States
• Baylor Charles A Sammons Cancer Center at Dallas — Dallas, Texas, United States
• Liverpool Hospital — Liverpool, New South Wales, Australia
• St Vincents Hospital Sydney — St Leonards, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• Royal Brisbane and Womens Hospital — Herston, Queensland, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Epworth Healthcare — East Melbourne, Victoria, Australia
• St Vincents Hospital Melbourne — Fitzroy, VIC, Victoria, Australia
• Barwon Health, University Hospital Geelong — Geelong, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Medizinische Universitaet Graz — Graz, Austria
• Landeskrankenhaus Salzburg — Salzburg, Austria
• Ziekenhuis Netwerk Antwerpen Stuivenberg — Antwerp, Belgium
• Universitair Ziekenhuis Brussel — Brussels, Belgium
• Lynn Cancer Center Boca Raton Regional Hospital, Lynn Cancer Institute — Boca Raton, Florida, United States

Full record on ClinicalTrials.gov

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