Study to Evaluate Safety Tolerability & Efficacy of Kyprolis (Carfilzomib) in Relapsed or Refractory Multiple Myeloma

NCT03934684 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20160372
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 17

Brief Summary

To characterize safety associated with the use of Kyprolis under the locally approved label.

Conditions

Relapsed Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

  A TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s). TEAEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03. Any clinically significant laboratory changes over time were recorded as TEAEs.

  From the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group)

• Number of Participants Who Experienced Serious TEAEs

  A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

  From the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group)

Study Arms (2)

Carfilzomib + Dexamethasone

EXPERIMENTAL

Drug: Carfilzomib + Dexamethasone * Carfilzomib 20 mg/m2 on days 1 and 2, and if tolerated, escalated to a target dose of 56 mg/m2 starting on day 8 of cycle 1 and thereafter. * Dexamethasone 20 mg taken by mouth or intravenously on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle. An individual subject will receive study treatment for a maximum of 3 years if the subject has not yet experienced disease progression

Drug: Drug: Carfilzomib + Dexamethasone

Carfilzomib+Lenalidomide+Dexamethasone

EXPERIMENTAL

Drug: Carfilzomib + Lenalidomide + Dexamethasone * Carfilzomib is 20 mg/m2 on days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m2 starting on day 8 of cycle 1 and thereafter. From cycle 13, the day 8 and day 9 doses of Carfilzomib will be omitted. * Lenalidomide 25 mg is taken orally on days 1 to 21. * Dexamethasone 40 mg on days 1, 8, 15, and 22 of the 28-day cycles. An individual subject will receive study treatment for a maximum of 18 months consistent with the approved use in this combination.

Drug: Drug: Carfilzomib + Lenalidomide + Dexamethasone

Interventions

Drug: Carfilzomib + Dexamethasone DRUG

Drug: Carfilzomib + Dexamethasone * Carfilzomib will be administered as a 30-minute infusion. * Dexamethasone will be taken by mouth or intravenously.

Also known as: Kyprolis

Carfilzomib + Dexamethasone

Drug: Carfilzomib + Lenalidomide + Dexamethasone DRUG

Drug: Carfilzomib + Lenalidomide + Dexamethasone * Carfilzomib will be administered as a 10 minute infusion. * Lenalidomide will be taken orally. * Dexamethasone will be taken by mouth or intravenously.

Also known as: Kyprolis

Carfilzomib+Lenalidomide+Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented RRMM after last treatment. Refractory is defined as meeting 1 or more of the following: Nonresponsive to most recent therapy (stable disease \[SD\] or progressive disease \[PD\]) while on treatment, or Disease progression within 60 days of discontinuation from the most recent therapy.
• Eligible to receive Kyprolis per the locally approved label.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Adequate hepatic function within 28 days prior to enrollment: bilirubin \< 1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times the ULN.
• Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9 /L within 28 days prior to enrollment. (Screening ANC should be independent of granulocyte- and granulocyte macrophage-colony stimulating factor support for at least 1 week and of pegylated granulocyte stimulating factor for ≥ 2 weeks).
• Hemoglobin ≥ 80 g/L within 28 days prior to enrollment. Subjects should not have received red blood cell (RBC) transfusions for at least 7 days prior to obtaining the screening hemoglobin.
• Platelet count ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if myeloma involvement in the bone marrow is ≥ 50%) within 28 days prior to enrollment. Subjects should not have received platelet transfusions for at least 7 days prior to obtaining the screening platelet count.
• Adequate renal function within 28 days prior to enrollment (either measured or calculated using a standard formula such as the Cockcroft and Gault): calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/min for subjects receiving KRd; calculated or measured CrCl of ≥ 15 mL/min for subjects receiving Kd.
• Left ventricular ejection fraction ≥ 40% as assessed by transthoracic echocardiogram (TTE) or multigated acquisition scan (MUGA).
• Females of childbearing potential (FCBP) must have a negative serum pregnancy test within the 10 to 14 days prior to enrollment and a negative urine pregnancy test within the 24 hours prior to day 1 of each cycle prior to dosing.
• Subject or legally acceptable representative has provided informed consent/assent prior to initiation of any study specific activities/procedures.

You may not qualify if:

• Waldenström macroglobulinemia.
• Plasma cell leukemia (\> 2.0 x 10\^9/L circulating plasma cells by standard differentials).
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Myelodysplastic síndrome.
• Primary amyloidosis (subjects with multiple myeloma with asymptomatic deposition of amyloid plaques found on biopsy would be eligible if all other criteria are met).
• History of other malignancy within the past 5 years, with the following exception\[s\]: Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. Adequately treated cervical carcinoma in situ without evidence of disease. Adequately treated breast ductal carcinoma in situ without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cáncer. Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
• Known immediate or delayed hypersensitivity reaction to Captisol (a cyclodextrin derivative used to solubilize Kyprolis).
• Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs.
• Intolerance to hydration.
• Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant echocardiogram (ECHO) abnormalities, screening ECG with corrected QT interval (QTc) of \> 470 msec, pericardial disease, or myocardial infarction within 4 months prior to enrollment.
• Infiltrative pulmonary disease and/or known pulmonary hypertension.
• Active infection within 14 days prior to enrollment requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents. Such infections must be fully resolved prior to initiating study treatment.
• Pleural effusions requiring thoracentesis within 14 days prior to enrollment.
• Ascites requiring paracentesis within 14 days prior to enrollment.
• Uncontrolled hypertension, defined as an average systolic blood pressure \> 159 mmHg or diastolic \> 99 mm/Hg despite optimal treatment (measured following European Society of Hypertension/European Society of Cardiology \[ESH/ESC\] 2013 guidelines.

Sponsors & Collaborators

• Amgen: lead

Study Sites (17)

Yashoda Hospital

Hyderabad, Andhra Pradesh, 500 082, India

Location

Apollo Hospital

Hyderabad, Andhra Pradesh, 500033, India

Location

M S Ramaiah Memorial Hospital

Bangalore, Karnataka, 560054, India

Location

K L E S Dr Prabhakar Kore Hospital and Medical Research Centre

Belagavi, Karnataka, 590010, India

Location

Cytecare Cancer Hospitals

Bengaluru, Karnataka, 560064, India

Location

Aster Medcity

Kochi, Kerala, 682027, India

Location

Government Medical College

Kozhikode, Kerala, 673008, India

Location

Tata Memorial Hospital

Mumbai, Maharashtra, 400 012, India

Location

Mumbai Oncocare Center

Mumbai, Maharashtra, 400 056, India

Location

Navsanjeevani Hospital

Nashik, Maharashtra, 422 002, India

Location

Heath Care Group Manavata Cancer Centre

Nashik, Maharashtra, 422 004, India

Location

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashtra, 411004, India

Location

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, Puducherry, 605 006, India

Location

Cancer Institute WIA

Chennai, Tamil Nadu, 600020, India

Location

Thangam Cancer Centre

Namakkal, Tamil Nadu, 637001, India

Location

Valentis Cancer Hospital

Meerut, Uttar Pradesh, 250001, India

Location

Netaji Subhash Chandra Bose Cancer Research Institute

Kolkata, West Bengal, 700 094, India

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Multiple Myeloma

Interventions

carfilzomib; Dexamethasone; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 2, 2019
• Study Start: September 16, 2019
• Primary Completion: March 23, 2023
• Study Completion: June 27, 2025
• Last Updated: August 6, 2025
• Results First Posted: January 2, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

Locations

IN (17)