Study to Demonstrate Clinical Benefit of Lenalidomide and Dexamethasone

NCT03809780 | Unknown Phase 2

• 1 other identifier: LENDER
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 2 years Progression Free Survival rates

  To evaluate the progression free survival rates at 2 years

  2year

Secondary Outcomes (5)

• 2 years Event-free survival rates

  2year

• 2 years Overall Survival rates

  2year

• Overall response rates

  assessed for approximately 2 years after administration

• Incidence of Treatment-Emergent Adverse Events by CTCAE

  assessed for approximately 2 years after administration

• Optimal dose in frail patients

  through study completion, an average of 1 year

Study Arms (1)

Lenalidomide,dexamethasone

EXPERIMENTAL

* High dose for intermediate risk group: lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly, every 4 weeks * Low dose for high risk group: lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly, every 4 weeks Schedule

Drug: Lenalidomide; Drug: Dexamethasone

Interventions

Lenalidomide DRUG

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

Lenalidomide,dexamethasone

Dexamethasone DRUG

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

Lenalidomide,dexamethasone

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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). We 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.
• Patients who are planned to receive lenalidomide according to license of lenalidomide and must be registered the Risk Management Program(Pregnancy Prevention Program) of each company.

You may not qualify if:

• 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.
• Subjects with unstable cardiac disease: MI within 6 months before study participation, NYHA heart failure class III-IV, uncontrolled hypertension/atrial fibrillation,
• Conditions requiring chronic steroid/immunosuppressive therapy such as RA, MS, lupus, that likely need additional steroid/IS treatment in addition to study treatment
• Grade \>=2 Peripheral neuropathy
• Subjects who are unwilling or unable to undergo antithrombotic therapy

Sponsors & Collaborators

• Kosin University Gospel Hospital: lead
• Celgene: collaborator

Study Sites (1)

Kosin University Gospel Hospital

Busan, Western, 49267, South Korea

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Dexamethasone

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)

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; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ho Sup Lee, MD, PhD.

  Kosin University Gospel Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. professor. Division of hematology-Oncology

Model Details: Elderly unfit patients with newly diagnosed multiple myeloma

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 18, 2019
• Study Start: March 11, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

KR (1)