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

  • STATUS
    Recruiting
  • End date
    Jun 26, 2025
  • participants needed
    100
  • sponsor
    Amgen
Updated on 16 March 2022

Summary

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

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.

Details
Condition Relapsed Refractory Multiple Myeloma
Treatment Drug: Carfilzomib + Dexamethasone, Drug: Carfilzomib + Lenalidomide + Dexamethasone
Clinical Study IdentifierNCT03934684
SponsorAmgen
Last Modified on16 March 2022

Eligibility

Yes No Not Sure

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) < 2.5 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

Exclusion Criteria

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
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
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