Multiple MyelomaPhase 2NCT04223661
Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy
A Phase 2 study testing Lenalidomide Pill, Dexamethasone and Daratumumab in people with Multiple Myeloma, run by Attaya Suvannasankha at 1 site in United States.
Trial summary
The purpose of this study is to determine if using a subject's baseline frailty score to guide the dosing of lenalidomide in a combination with dexamethasone and daratumumab (DRd lite). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Lenalidomide Pill, Dexamethasone and Daratumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to 31 Dec 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Newly diagnosed, symptomatic MM who have frailty score of 1 or higher; patients age ≥ 75 or younger patients with comorbidities (<75):
- Frailty score takes into account age, as well as the geriatric assessments incorporating 3 tools: the Katz Activity of Daily Living (ADL), the Lawton Instrumental Activity of Daily Living (IADL), and the Charlson Comorbidity Index (CCI)-see detailed tables in Appendix A.
- Score calculation tool: www.myelomafrailtyscorecalculator.net
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2 within 14 days prior to registration.
- Measurable disease according to the International Myeloma Working Group criteria:
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- Serum M-protein ≥1 g/dL
- Urine M-protein ≥200 mg/24 h, or
- Serum FLC (free light-chain) assay: involved FLC level ≥10 mg/dL provided serum FLC ratio is abnormal
- Clonal bone marrow plasma cells ≥ 10%
- No prior systemic therapy for myeloma is allowed. Surgery such as vertebroplasty or intramedullary rod placements, and local palliative radiation are allowed as long as subjects have no residual AEs (adverse events) from prior therapies at the time of screening
- Life expectancy of >3 months as determined by the treating physician.
- Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 14 days prior to registration.
- System Laboratory Value Hematological Absolute Neutrophil Count (ANC) ≥ 1.0 K/mm3 Platelet ≥ 50 K/mm3 Hemoglobin (Hgb) ≥ 8 g/dL Renal Calculated creatinine clearance ≥ 30 mL/min using 24 hour urine creatinine clearance Hepatic Bilirubin ≤ 2 × upper limit of normal (ULN) Aspartate aminotransferase (AST) ≤ 2 × ULN Alanine aminotransferase (ALT) ≤ 2 × ULN Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤ 2 × ULN
- Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
- Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use one highly effective method of contraception and one barrier method from the time of informed consent until 3 months after treatment discontinuation. The birth control method must include one highly effective form of contraception (tubal ligation, intrauterine device [IUD], hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner's vasectomy with confirmation of procedure) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap).
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
Who cannot join
- Prior or concurrent exposure to any of the following:
- To daratumumab or other anti-CD-38 therapies
- Maximum of 40 mg dexamethasone (or equivalent) daily for a maximum of 4 days consecutively up to 21 days of 1st dose
- Exposure to investigational drug (including investigational vaccines) or invasive investigational medical device for any indication within 4 weeks or 5 pharmacokinetic half-lives, whichever is longer, before enrollment [Cycle 1, Day 1 / Randomization]
- Focal radiation therapy within 14 days prior to enrollmentrandomization with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma. Radiotherapy within 14 days prior to enrollmentrandomization on measurable extramedullary plasmacytoma is not permitted even in the setting of palliation for symptomatic management.
- Known allergies, hypersensitivity, or intolerance to any of the study drugs, hyaluronidase, mannitol, sorbitol or, corticosteroids, monoclonal antibodies, human proteins, or their excipients.
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- Active infection requiring systemic therapy
- Poorly controlled reactive airway diseases including COPD (chronic obstructive pulmonary disease) or asthma. In subjects with underlying disease of COPD or asthma, spirometric analysis is recommended. Subjects with FEV1 (forced expiratory volume at one second) < 50% is excluded.
- Other medical conditions interfering with the administration of and compliance to treatments such as Cardiac disease (such as myocardial infarction within past 6 months, uncontrolled cardiac arrhythmia, congestive cardiac failure), major surgeries within past 2 weeks, plasmapheresis within past 28 days
- Plasma cell leukemia or amyloidosis
- Pregnant or breastfeeding
- Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years.
- Active central nervous system (CNS) involvement by MM
- Contraindication to receive antiplatelet or anticoagulant prophylaxis
- Subject is:
- seropositive for human immunodeficiency virus (HIV)
- seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (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 by PCR.
- seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Roudebush Medical Center
Indianapolis, Indiana, 46202
About this study
Official title: Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy in Elderly, Frail Newly Diagnosed Myeloma (MMY2035)
The purpose of this study is to determine if using a subject's baseline frailty score to guide the dosing of lenalidomide in a combination with dexamethasone and daratumumab (DRd lite).
Read the detailed description
This is a multi-institution, prospective, single arm Phase II trial of lenalidomide in a combination with dexamethasone and daratumumab (DRd lite) with no blinding or randomization. This study will enroll 44 patients over 36 months.
Primary Objectives:
- Evaluate Response rate
- Evaluate Side effects
Secondary Objectives:
- Evaluate Time on therapy
- Evaluate Progression free survival
- Evaluate Time to the next line of therapy
- Assess Quality of life
- Conditions
- Multiple Myeloma
- Being tested
- Lenalidomide Pill, Dexamethasone, Daratumumab
- Keywords
- multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide PillDrug
Lenalidomide will be administered PO on Days 1 through 21 of each 28 day cycle at the dose according to the frailty score and creatinine clearance.
DexamethasoneDrug
Dexamethasone will be administered at 20 mg per week. During weeks when the subject receives an infusion of daratumumab, dexamethasone will be administered on infusion days at a dose of 20 mg IV before the infusion.
DaratumumabDrug
Daratumumab (1800 mg) will be administered by SC injection by manual push over approximately 3 - 5 minutes in the abdominal subcutaneous tissues in the left/right locations, alternating between individual doses. The volume of the SC solution will be 15 mL for the 1800 mg dose
| Study group | Role | What they receive |
|---|---|---|
| Frailty score 1 | Experimental | Starting dose of lenalidomide in subjects who are intermediately fit (frailty score of 1) will be 10 mg day 1-21 of 28 day cycle and escalate to 15 mg
All subjects will receive 20mg Dexamathasone weekly (split dosing is allowed) and 16mg Daratumumab (cycle 1-2 on days 1,8,15 and 22. Cycles 3-6 on days 1 and 15. Cycle 7 and beyond on day 1) during the course of the trial. Receives: Drug: Lenalidomide Pill; Drug: Dexamethasone; Drug: Daratumumab |
| Frailty Score 2 or above | Experimental | Starting dose of lenalidomide in frail subjects (frailty score of 2 or higher) will be 5 mg day 1-21 of 28 day cycle, and escalate to 10 mg.
All subjects will receive 20mg Dexamathasone weekly (split dosing is allowed) and 16mg Daratumumab (cycle 1-2 on days 1,8,15 and 22. Cycles 3-6 on days 1 and 15. Cycle 7 and beyond on day 1) during the course of the trial. Receives: Drug: Lenalidomide Pill; Drug: Dexamethasone; Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Based on the International Myeloma Working group criteria
Measured: 3 months
Response Rate
Based on the International Myeloma Working group criteria
Measured: 6 months
Response Rate
Based on the International Myeloma Working group criteria
Measured: 12 months
Response Rate
Based on the International Myeloma Working group criteria
Measured: Best response achieved (up to but no longer than 2 years)
Side Effects
Evaluated based on CTCAE version 5.0
Measured: up to 730 days
Secondary outcomes (5)
Time on therapy
From the start of treatment till the end of treatment (of all 3 drugs)
Measured: up to 730 days
Progression free survival
From the start of the treatment until the date of disease progression or death due to any cause. Subjects not progressing or dying will be censored at last disease evaluation date.
Measured: up to 730 days
Time to the next line of therapy
Duration between the start of the study therapy of all 3 drugs and the start of any new line of therapy.
Measured: up to 730 days
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
EORTC QLQ-C30
Measured: Monthly (months 1-6), then every 3 months until treatment end (up to but no longer than 2 years)
Quality of Life- Myeloma
EORTC QLQ-MY20
Measured: Monthly (months 1-6), then every 3 months until treatment end (up to but no longer than 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start6 Dec 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: lack of funding
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
- Non-randomised
- Intervention model
- Single group
- Model description
- Starting dose of lenalidomide in subjects who are intermediately fit (frailty score of 1) will be 10 mg day 1-21 of 28 day cycle and escalate to 15 mg, and in frail subjects (frailty score of 2 or higher) will be 5 mg, and escalate to 10 mg. All subjects will receive 20mg Dexamathasone and 1800mg Daratumumab during the course of the trial.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attaya Suvannasankha
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, Indiana Institute for Medical Research
- Responsible party
- Sponsor-investigator, Attaya Suvannasankha, Indiana University
- Investigators
- Attaya Suvannasankha, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223661
- Sponsor's protocol ID
- CTO-IUSCC-0719
- Status last verified
- Dec 2022
- First submitted
- 3 Dec 2019
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy in Elderly, Frail Newly Diagnosed Myeloma (MMY2035)
- ClinicalTrials.gov ID
- NCT04223661
- Acronym / sponsor ID
- CTO-IUSCC-0719
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Attaya SuvannasankhaUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, Indiana Institute for Medical Research
- Study start
- 6 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Jan 2020 (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.
The purpose of this study is to determine if using a subject's baseline frailty score to guide the dosing of lenalidomide in a combination with dexamethasone and daratumumab (DRd lite).
Detailed description
This is a multi-institution, prospective, single arm Phase II trial of lenalidomide in a combination with dexamethasone and daratumumab (DRd lite) with no blinding or randomization. This study will enroll 44 patients over 36 months.
Primary Objectives:
- Evaluate Response rate
- Evaluate Side effects
Secondary Objectives:
- Evaluate Time on therapy
- Evaluate Progression free survival
- Evaluate Time to the next line of therapy
- Assess Quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Starting dose of lenalidomide in subjects who are intermediately fit (frailty score of 1) will be 10 mg day 1-21 of 28 day cycle and escalate to 15 mg, and in frail subjects (frailty score of 2 or higher) will be 5 mg, and escalate to 10 mg. All subjects will receive 20mg Dexamathasone and 1800mg Daratumumab during the course of the trial.
| Arm | Type | Receives |
|---|---|---|
| Frailty score 1 | Experimental | Drug: Lenalidomide Pill, Drug: Dexamethasone, Drug: DaratumumabStarting dose of lenalidomide in subjects who are intermediately fit (frailty score of 1) will be 10 mg day 1-21 of 28 day cycle and escalate to 15 mg All subjects will receive 20mg Dexamathasone weekly (split dosing is allowed) and 16mg Daratumumab (cycle 1-2 on days 1,8,15 and 22. Cycles 3-6 on days 1 and 15. Cycle 7 and beyond on day 1) during the course of the trial. |
| Frailty Score 2 or above | Experimental | Drug: Lenalidomide Pill, Drug: Dexamethasone, Drug: DaratumumabStarting dose of lenalidomide in frail subjects (frailty score of 2 or higher) will be 5 mg day 1-21 of 28 day cycle, and escalate to 10 mg. All subjects will receive 20mg Dexamathasone weekly (split dosing is allowed) and 16mg Daratumumab (cycle 1-2 on days 1,8,15 and 22. Cycles 3-6 on days 1 and 15. Cycle 7 and beyond on day 1) during the course of the trial. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (17 listed)
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Newly diagnosed, symptomatic MM who have frailty score of 1 or higher; patients age ≥ 75 or younger patients with comorbidities (<75):
- Frailty score takes into account age, as well as the geriatric assessments incorporating 3 tools: the Katz Activity of Daily Living (ADL), the Lawton Instrumental Activity of Daily Living (IADL), and the Charlson Comorbidity Index (CCI)-see detailed tables in Appendix A.
- Score calculation tool: www.myelomafrailtyscorecalculator.net
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2 within 14 days prior to registration.
Key exclusion criteria (18 listed)
- Prior or concurrent exposure to any of the following:
- Known allergies, hypersensitivity, or intolerance to any of the study drugs, hyaluronidase, mannitol, sorbitol or, corticosteroids, monoclonal antibodies, human proteins, or their excipients.
- Active infection requiring systemic therapy
- Poorly controlled reactive airway diseases including COPD (chronic obstructive pulmonary disease) or asthma. In subjects with underlying disease of COPD or asthma, spirometric analysis is recommended. Subjects with FEV1 (forced expiratory volume at one second) < 50% is excluded.
- Other medical conditions interfering with the administration of and compliance to treatments such as Cardiac disease (such as myocardial infarction within past 6 months, uncontrolled cardiac arrhythmia, congestive cardiac failure), major surgeries within past 2 weeks, plasmapheresis within past 28 days
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 PillLenalidomide will be administered PO on Days 1 through 21 of each 28 day cycle at the dose according to the frailty score and creatinine clearance. | Drug | Frailty Score 2 or above, Frailty score 1 |
| DexamethasoneDexamethasone will be administered at 20 mg per week. During weeks when the subject receives an infusion of daratumumab, dexamethasone will be administered on infusion days at a dose of 20 mg IV before the infusion. | Drug | Frailty Score 2 or above, Frailty score 1 |
| DaratumumabDaratumumab (1800 mg) will be administered by SC injection by manual push over approximately 3 - 5 minutes in the abdominal subcutaneous tissues in the left/right locations, alternating between individual doses. The volume of the SC solution will be 15 mL for the 1800 mg dose | Drug | Frailty Score 2 or above, Frailty score 1 |
Primary outcome
Response Rate
Time frame: 3 months
Based on the International Myeloma Working group criteria
Response Rate
Time frame: 6 months
Based on the International Myeloma Working group criteria
Response Rate
Time frame: 12 months
Based on the International Myeloma Working group criteria
Response Rate
Time frame: Best response achieved (up to but no longer than 2 years)
Based on the International Myeloma Working group criteria
Side Effects
Time frame: up to 730 days
Evaluated based on CTCAE version 5.0
5 secondary outcomes
Time on therapy
Time frame: up to 730 days
Progression free survival
Time frame: up to 730 days
Time to the next line of therapy
Time frame: up to 730 days
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: Monthly (months 1-6), then every 3 months until treatment end (up to but no longer than 2 years)
Quality of Life- Myeloma
Time frame: Monthly (months 1-6), then every 3 months until treatment end (up to but no longer than 2 years)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
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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.
Attaya Suvannasankha, MD principal investigator
Indiana University
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 Pill, Dexamethasone and Daratumumab in people with Multiple Myeloma, run by Attaya Suvannasankha at 1 site in United States.
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 17 inclusion and 18 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: withdrawn, as of the sponsor's last update on 8 Dec 2022. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Response Rate (time frame: 3 months). The study lists 5 primary outcomes in all. 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 8 Dec 2022.