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Study to Demonstrate Clinical Benefit of Lenalidomide and Dexamethasone (LENDER)

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ClinicalTrials.gov Identifier: NCT03809780
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : September 24, 2020
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Ho Sup Lee, Kosin University Gospel Hospital

Study Description
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Brief Summary:
Recent prospective multicenter phase II study assessed the efficacy and tolerability of lower dose lenalidomide (15mg) and dexamethasone (20mg) in frail patients with relapsed or refractory MM. The overall response rate was 71% including complete remission of 15%. Median progression free survival and overall survival were 8.9 and 30.5 months. In addition, grade 3-4 toxicities such as neutropenia, and infections were reduced. This study supported that lower dose lenalidomide may be optimal stating dose for elderly patients with frailty.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Lenalidomide Drug: Dexamethasone Phase 2

Detailed Description:

Multiple myeloma (MM) is a malignant plasma cell disorder that occurs mainly in older adults. The median age at diagnosis is approximately 70 years, and two-thirds of patients with newly diagnosed MM are older than 65years. As life expectancy increases, the population of older individuals grows. Consequently, the number of patients with MM, especially elderly patients, is expected to increase considerably in the next two decades. Elderly patients may have a variety of comorbidities and reduced physical function at diagnosis, and may be intolerable to standard chemotherapy.

Recent prospective multicenter phase II study assessed the efficacy and tolerability of lower dose lenalidomide (15mg) and dexamethasone (20mg) in frail patients with relapsed or refractory MM[8]. The overall response rate was 71% including complete remission of 15%. Median progression free survival and overall survival were 8.9 and 30.5 months. In addition, grade 3-4 toxicities such as neutropenia, and infections were reduced. This study supported that lower dose lenalidomide may be optimal stating dose for elderly patients with frailty.

Therefore, investigators thought that the use of lower dose of lenalidomide in the frail group is expected to increase the effectiveness as it is used for a long time while reducing toxicity.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: multiple myeloma
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Study to Demonstrate Clinical Benefit of Lenalidomide and Dexamethasone in Elderly Unfit Patients With Newly Diagnosed Multiple Myeloma
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 3, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lenalidomide,dexamethasone
  • high dose: lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly
  • low dose: lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly Schedule
 Drug: Lenalidomide
-high dose: [lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly] -Low dose: [lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly]

Drug: Dexamethasone
-high dose: [lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly] -Low dose: [lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly]


Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: 2year ]
    Progression Free Survival rates


Eligibility Criteria
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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥ 70 years unfit and ineligible transplantation in patients with newly diagnosed MM
  • Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
  • Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
  • Symptomatic MM based on standard CRAB criteria.
  • Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, ≥ 0.5 g/dL of M-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours. For patients with oligo or non-secretory MM, it is required that they have
  • Measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an abnormal free light chain ratio (n.v.: 0.26-1.65). The investigators anticipate that less than 10% of patients admitted to this study will be oligo- or non-secretory MM with free light chains only in order to maximize interpretation of benefit results.
  • The frailty of the patient will be calculated by R-MCI and scoring according to renal function, pulmonary function, activity, frailty, age, and cytogenetics, 0-3 points are low risk (fit) risk (inadequate) and 7 or higher will be classified as high risk (frail). Only inadequate and frail can be included.
  • Patients must meet the following clinical laboratory criteria with 21 days of starting treatment:
  • Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet ≥ 50,000/mm3 (≥ 30,000/mm3 if myeloma involvement in the bone marrow is >50%)
  • Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
  • Calculated creatinine clearance ≥ 30mL/min or creatinine < 3mg/dL

Exclusion Criteria:

  • Pregnant or lactating females.
  • Male patients not agreeing to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study.
  • Females of childbearing potential not agreeing to use two acceptable methods for contraception (e.g. a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  • Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid < to the equivalent of dexamethasone 40 mg/day for 4 days).
  • Any significant medical disease or conditions that, in the investigator's opinion, may interfere with protocol adherence or subject's ability to give informed consent or could place the subject at unacceptable risk.
  • Presence of clinical active infectious hepatitis type B or C, classified into Child-Pugh class C (see Appendix V) and HIV.
  • Presence of acute active infection requiring antibiotics or infiltrative pulmonary disease.
  • Contraindication to any of the required drugs or supportive treatments.
  • prior history of malignancies, other than MM, unless the subject had been free of disease for >= 3 years with the following exceptions: Basal cell CA of skin, Squamous cell CA of skin, CA in situ of cervix and breast, incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809780


Locations
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Korea, Republic of
Kosin University Gospel Hospital Recruiting
Busan, Western, Korea, Republic of, 49267
Contact: Ho Sup Lee, MI    82-51-990-6363    hs3667@hanmail.net   
Sponsors and Collaborators
Kosin University Gospel Hospital
Celgene
More Information
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Responsible Party: Ho Sup Lee, MD, PhD. associate professor,Division of hematology-Oncology, Kosin University Gospel Hospital
ClinicalTrials.gov Identifier: NCT03809780    
Other Study ID Numbers: LENDER
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
 Lenalidomide
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents