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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03934684

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted October 9, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Relapsed Refractory Multiple Myeloma
  • Intervention/Treatment: Drug: Drug: Carfilzomib + Dexamethasone
    Drug: Drug: Carfilzomib + Lenalidomide + Dexamethasone
  • Phase: Phase 4
Detailed Description

Kyprolis® (K; carfilzomib) was approved in India on 17 January 2017 as a prescription medication in combination with dexamethasone (Kd) or with lenalidomide (Revlimid®) plus dexamethasone (KRd) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) following 1 to 3 prior lines of therapy. This non-comparative, interventional phase 4 study is designed to fulfil the post-marketing requirement to assess safety, tolerability, and efficacy of Kyprolis on Indian subjects with RRMM as per the locally approved label.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Post-marketing Phase 4 Study to Evaluate Safety, Tolerability, and Efficacy of Kyprolis® (Carfilzomib) in Indian Patients With Relapsed or Refractory Multiple Myeloma: A Prospective, Open-label, Non-comparative, Multicenter Study
  • Actual Study Start Date: September 2019
  • Estimated Primary Completion Date: April 2022
  • Estimated Study Completion Date: August 2024
Arms and interventions
Arm Intervention/treatment
Experimental: Carfilzomib + Dexamethasone
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
Drug: Carfilzomib + Dexamethasone Carfilzomib will be administered as a 30-minute infusion. Dexamethasone will be taken by mouth or intravenously.
Experimental: Carfilzomib+Lenalidomide+Dexamethasone
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
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.
Outcome Measures
  • Primary Outcome Measures: 1. Number of participants with treatment-emergent adverse events as assessed by CTCAE v4.03 [ Time Frame: From enrollment up to the post treatment follow-up visit, which is 19 months for Carfilzomib + Lenolidamide + Dexamethasone arm or until disease progression or a maximum of 3 years for the Carfilzomib + Dexamethasone arm. ]
    Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03
  • Secondary Outcome Measures: 1. Progression Free Survival [ Time Frame: From enrollment up to the post treatment follow-up visit, which is 19 months for Carfilzomib + Lenolidamide + Dexamethasone arm or until disease progression or a maximum of 3 years for the Carfilzomib + Dexamethasone arm. ]
    Progression Free Survival is defined as the time from first dose of study treatment until the earliest date of disease progression or death due to any cause
  • 2. Overall Response Rate [ Time Frame: From enrollment up to the post treatment follow-up visit, which is 19 months for Carfilzomib + Lenolidamide + Dexamethasone arm or until disease progression or a maximum of 3 years for the Carfilzomib + Dexamethasone arm. ]
    Overall Response Rate is defined as the proportion of subjects with either a best overall response of the stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) CBR is defined as the proportion of subjects with either a best overall response of sCR, CR, VGPR, PR, and minimal response (MR)
  • 3. Clinical Benefit Rate [ Time Frame: From enrollment up to the post treatment follow-up visit, which is 19 months for Carfilzomib + Lenolidamide + Dexamethasone arm or until disease progression or a maximum of 3 years for the Carfilzomib + Dexamethasone arm. ]
    Clinical Benefit Rate is defined as the proportion of subjects with either a best overall response of sCR, CR, VGPR, PR, and minimal response (MR)
  • 4. Time to Response [ Time Frame: From enrollment up to the post treatment follow-up visit, which is 19 months for Carfilzomib + Lenolidamide + Dexamethasone arm or until disease progression or a maximum of 3 years for the Carfilzomib + Dexamethasone arm. ]
    Time To Response is calculated only for subjects who achieve a best overall response of PR or better and is defined as the time from first dose of study treatment to the earliest date a response of PR or better is first achieved and subsequently confirmed
  • 5. Duration of Response [ Time Frame: From enrollment up to the post treatment follow-up visit, which is 19 months for Carfilzomib + Lenolidamide + Dexamethasone arm or until disease progression or a maximum of 3 years for the Carfilzomib + Dexamethasone arm. ]
    Duration of Response is defined as the time from initial response (sCR, CR, VGPR, or PR) to date of disease progression
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- 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) 2.0 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.

- Known human immunodeficiency virus (HIV) infection, hepatitis C infection (subjects
with hepatitis C that achieve a sustained virologic response following antiviral
therapy are allowed).

- Ongoing graft-versus-host disease.

- Subjects with grade 3 or worse neuropathy within 14 days prior to enrollment.

- Antitumor therapy (eg, chemotherapy, immunotherapy, antibody therapy) or
investigational agent within 28 days before enrollment or not recovered from any acute
toxicity.

- Subjects on immunosuppressive therapy for graft versus host disease, even if it has
resolved.

- Glucocorticoid therapy within 14 days before first dose that exceeds a cumulative dose
of 160 mg or dexamethasone or equivalent dose of other corticosteroids.

- Focal radiation therapy within 7 days before enrollment. Radiation therapy to an
extended field involving significant volume of bone marrow within 28 days prior to
enrollment (ie, prior radiation must have been to less than 30% of the bone marrow).

- Autologous stem cell transplant less than 100 days prior to enrollment.

- Prior treatment with Kyprolis (carfilzomib).

- Currently receiving treatment in another investigational device or drug study, or less
than 30 days since ending treatment on another investigational device or drug study.
Other investigational procedures while participating in this study are excluded.

- Female subject is pregnant or breastfeeding or planning to become pregnant or
breastfeed during treatment, during any breaks (interruptions) in the treatment, and
for an additional 30 days after the last dose of Kyprolis. Females of childbearing
potential should only be included in the study after a confirmed menstrual period and
a negative highly sensitive urine or serum pregnancy test.

- Female subjects of childbearing potential unwilling to use 1 highly effective method
of contraception during treatment, during any breaks (interruptions) in the treatment,
and for an additional 30 days after the last dose of Kyprolis.

NOTE: Female subjects of childbearing potential being treated with lenalidomide must agree
to use 2 methods of contraception for at least 28 days before starting treatment, during
treatment, during any breaks (interruptions) in the treatment, and for an additional 30
days after the last dose of treatment.

• Male subjects with a female partner of childbearing potential who are unwilling to
practice sexual abstinence (refrain from heterosexual intercourse) or use contraception
during treatment and for an additional 90 days after the last dose of Kyprolis.

NOTE: Male subjects being treated with lenalidomide must agree to use a male condom with
spermicide even if they have undergone a successful vasectomy.

- Male subjects with a pregnant partner who are unwilling to practice abstinence or use
a condom during treatment and for an additional 90 days after the last dose of
Kyprolis.

- Male subjects unwilling to abstain from donating sperm during treatment and for an
additional 90 days after the last dose of Kyprolis.

- Subject likely to not be available to complete all protocol required study visits or
procedures, and/or to comply with all required study procedures to the best of the
subject and investigator's knowledge.

- History or evidence of any other clinically significant disorder, condition or disease
(with the exception of those outlined above) that, in the opinion of the investigator
or Amgen physician, if consulted, would pose a risk to subject safety or interfere
with the study evaluation, procedures or completion.

- Active hepatitis B virus (HBV) infection. Subjects with positive hepatitis B surface
antigen (HBsAg) or core antibody (anti-HBc) that achieve sustained virologic response
with antiviral therapy directed at hepatitis B are allowed. Subjects with known
history or resolved infection (negative for HBsAg but positive for antibodies to
surface antigen, and/or core antigen) must be screened with HBV DNA levels. EXCEPTION:
Subjects with serologic findings suggestive of HBV vaccination (hepatitis B surface
antibody [anti-HBs] positivity as the only serologic marker) AND a known history of
prior HBV vaccination, do not need to be tested for HBV DNA.

Contacts and Locations
Contacts

Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
Show 11 Study Locations
Sponsors and Collaborators

Amgen

Investigators

Study Director: MD Amgen

More Information
  • Responsible Party: Amgen
  • ClinicalTrials.gov Identifier: NCT03934684 History of Changes
  • Other Study ID Numbers: 20160372
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: October 9, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (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.
  • URL: http://www.amgen.com/datasharing
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Multiple Myeloma Neoplasms, Plasma Cell