Multiple MyelomaPhase 2LENDERNCT03809780
Study to Demonstrate Clinical Benefit of Lenalidomide and Dexamethasone
A Phase 2 study testing Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Kosin University Gospel Hospital at 1 site in South Korea.
Trial 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%. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Lenalidomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Mar 2019to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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,
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Phase II Study to Demonstrate Clinical Benefit of Lenalidomide and Dexamethasone in Elderly Unfit Patients With Newly Diagnosed Multiple Myeloma
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Lenalidomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
-high dose: [lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly] -Low dose: [lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly]
DexamethasoneDrug
-high dose: [lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly] -Low dose: [lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly]
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 years Progression Free Survival rates
To evaluate the progression free survival rates at 2 years
Measured: 2year
Secondary outcomes (5)
2 years Event-free survival rates
To evaluate the event free survival rates at 2 years
Measured: 2year
2 years Overall Survival rates
To evaluate the overall survival rates at 2 years
Measured: 2year
Overall response rates
To evaluated the overall response rates, defined as more than partial response.
Measured: assessed for approximately 2 years after administration
Incidence of Treatment-Emergent Adverse Events by CTCAE
To assess the incidence of lenalidomide plus dexamethasone therapy
Measured: assessed for approximately 2 years after administration
Optimal dose in frail patients
To assess the optimal dose of lenalidomide for frail patients with newly diagnosed multiple myeloma.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start11 Mar 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Elderly unfit patients with newly diagnosed multiple myeloma
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kosin University Gospel Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Principal investigator, Ho Sup Lee, Kosin University Gospel Hospital
- Investigators
- Ho Sup Lee, MD, PhD., Principal investigator, Kosin University Gospel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809780
- Sponsor's protocol ID
- LENDER
- Acronym
- LENDER
- Status last verified
- Jun 2023
- First submitted
- 15 Jan 2019
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study to Demonstrate Clinical Benefit of Lenalidomide and Dexamethasone in Elderly Unfit Patients With Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03809780
- Acronym / sponsor ID
- LENDER / LENDER
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kosin University Gospel HospitalUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Elderly unfit patients with newly diagnosed multiple myeloma
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide,dexamethasone | Experimental | Drug: Lenalidomide, Drug: Dexamethasone* 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenalidomide-high dose: [lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly] -Low dose: [lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly] | Drug | Lenalidomide,dexamethasone |
| Dexamethasone-high dose: [lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly] -Low dose: [lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly] | Drug | Lenalidomide,dexamethasone |
Primary outcome
2 years Progression Free Survival rates
Time frame: 2year
To evaluate the progression free survival rates at 2 years
5 secondary outcomes
2 years Event-free survival rates
Time frame: 2year
2 years Overall Survival rates
Time frame: 2year
Overall response rates
Time frame: assessed for approximately 2 years after administration
Incidence of Treatment-Emergent Adverse Events by CTCAE
Time frame: assessed for approximately 2 years after administration
Optimal dose in frail patients
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho Sup Lee, MD, PhD. principal investigator
Kosin University Gospel Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Kosin University Gospel Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 years Progression Free Survival rates (time frame: 2year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.