Compare Lenalidomide and Subcutaneous Daratumumab vs Lenalidomide and Dexamethasone in Frail Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy (IFM2017_03)

April 1, 2026 updated by: University Hospital, Lille

A Phase III Study Comparing Lenalidomide and Subcutaneous Daratumumab (R-Dara SC) vs Lenalidomide and Dexamethasone (Rd) in Frail Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy

This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital team work on a medical research study) study in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) and who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT). The primary hypothesis of this study is that subcutaneous Daratumumab in combination with Lenalidomide will prolong progression-free survival and likely induce less toxicity as compared with Lenalidomide and dexamethasone, in elderly frail subjects with newly diagnosed Multiple myeloma who are ineligible for high dose chemotherapy and ASCT

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary hypothesis of this study is that subcutaneous Daratumumab in combination with Lenalidomide will prolong progression-free survival and likely induce less toxicity as compared with Lenalidomide and dexamethasone, in elderly frail subjects with newly diagnosed Multiple myeloma who are ineligible for high dose chemotherapy and ASCT

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
294

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France
        • CHRU Jean Minjoz
      • Blois, France
        • Ch Blois Simone Veil
      • Bourg-en-Bresse, France
        • CH Fleyriat
      • Brest, France
        • Chru Brest Site Hopital Morvan
      • Caen, France
        • CHU de Caen Normandie
      • Cesson-Sévigné, France
        • Hopital Prive Sevigne - Cesson
      • Dijon, France
        • CHU Dijon Bourgogne
      • Grenoble, France
        • Chu de Grenoble
      • La Rochelle, France
        • Gpe Hospitalier La Rochelle-Re-Aunis
      • Le Coudray, France
        • Ch Chartres Louis Pasteur-Le Coudray
      • Lille, France
        • Hôpital Claude Huriez, CHU
      • Marseille, France
        • Institut Paoli Calmettes
      • Mont-de-Marsan, France
        • Chi Mont de Marsan Et Pays Des Sources
      • Montpellier, France
        • CHU Montpellier
      • Nantes, France
        • Chu de Nantes Site Hotel Dieu Hme
      • Nice, France
        • CHU De Nice Hopital De l'Archet
      • Pessac, France, 33604
        • Hopital Haut-Leveque - Chu
      • Périgueux, France
        • Centre Hospitalier de Perigueux
      • Rennes, France
        • Chru Rennes Site Pontchaillou
      • Saint-Quentin, France
        • Centre Hospitalier de Saint Quentin
      • St-Malo, France
        • Centre Hospitalier Saint-Malo
      • Toulouse, France
        • Oncopole Chu Toulouse
      • Tours, France
        • CHU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject must be at least 65 years of age.
  2. Subject must have documented multiple myeloma satisfying the CRAB criteria and measurable disease.
  3. Newly diagnosed and not considered candidate for high-dose chemotherapy with SCT.
  4. Subject must have a Frailty Score ≥ 2

  5. Subject must have within 5 days prior to first drug intake (C1D1) pretreatment clinical laboratory values meeting the following criteria during the Screening Phase:

    • hemoglobin ≥7.5 g/dL
    • absolute neutrophil count ≥1.0 x 109/L
    • platelet count ≥70 x 109/L
    • aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN)
    • alanine aminotransferase (ALT) ≤2.5 x ULN
    • total bilirubin ≤2.0 x ULN
    • creatinine clearance≥30mL/min
  6. Measurable ISS with β2-microglobulin and albumin values for randomization
  7. A man who is sexually active with a woman of childbearing potential must agree to use a latex or synthetic condom, even if they had a successful vasectomy. All men must also not donate sperm during the study, for 4 weeks after the last dose of lenalidomide, and for 4 months after the last dose of daratumumab. Women participating in this study must be postmenopausal.
  8. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF.
  9. Subjects affiliated with an appropriate social security system.

Exclusion Criteria:

  1. Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma.
  2. Subject has a diagnosis of Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
  3. Subject has prior or current systemic therapy or SCT for multiple myeloma
  4. Subject has a history of malignancy (other than multiple myeloma) within 5 years before the date of randomization
  5. Subject has had radiation therapy within 14 days of randomization.
  6. Subject has had plasmapheresis within 28 days of randomization.
  7. Subject is exhibiting clinical signs of meningeal involvement of multiple myeloma.
  8. Subject has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume [FEV] in 1 second <60% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (intermittent asthma is allowed).
  9. Subject is known to be seropositive for history of human immunodeficiency virus (HIV)
  10. Seropositive for hepatitis B.
  11. (Known to be) seropositive for hepatitis C
  12. Subject has any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.

  13. Subject has clinically significant cardiac disease, including:

    • myocardial infarction within 1 year before randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function
    • uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities
    • screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) >470 msec
  14. Subject has known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients
  15. Subject has plasma cell leukemia or POEMS syndrome
  16. Subject is known or suspected of not being able to comply with the study protocol. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.
  17. Subject has had major surgery within 2 weeks before randomization or has not fully recovered from surgery.
  18. Subject has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before randomization or is currently enrolled in an interventional investigational study.
  19. Refusal to consent or protected by legal regime ( guardianship, trusteeship)
  20. Subject has contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism
  21. Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: Experimental group

Daratumumab SC 1800 mg

  • once every week for 8 weeks
  • then once every other week for 16 weeks
  • thereafter once every 4 weeks, until progression Lenalidomide PO (25mg): days 1 through 21 of each 28-day cycle, until progression Dexamethasone PO (20mg): days 1, 8, 15, 22 of a 28-day cycle, for the first 2 cycles, then discontinued
Drug: Daratumumab SC in combination with Lenalidomide

Daratumumab SC 1800 mg

  • once every week for 8 weeks
  • then once every other week for 16 weeks
  • thereafter once every 4 weeks, until progression
Drug: Lenalidomide PO (25mg)
Lenalidomide PO (25mg): days 1 through 21 of each 28-day cycle, until progression
Drug: Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression
Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression
Sham Comparator: Arm 2: Control group
Lenalidomide PO (25mg): days 1 through 21 of each 28-day cycle, until progression Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression
Drug: Lenalidomide PO (25mg)
Lenalidomide PO (25mg): days 1 through 21 of each 28-day cycle, until progression
Drug: Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression
Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of the efficacy of Daratumumab SC injection when combined with Lenalidomide (R-Dara SC) vs Lenalidomide and Dexamethasone (Rd): PFS
Time Frame: From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
The primary objective is to compare the efficacy of Daratumumab SC injection when combined with Lenalidomide (R-Dara SC) to that of Lenalidomide and Dexamethasone (Rd), in terms of PFS in frail subjects with newly diagnosed myeloma who are not candidates for high dose chemotherapy and autologous stem cell transplant.
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time-to-treatment failure
Time Frame: From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Time-to-next treatment
Time Frame: From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
PFS2 time
Time Frame: From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Overall survival (OS) time
Time Frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 84months
Overall survival (OS) time,
From date of randomization until the date of death from any cause, whichever came first, assessed up to 84months
Complete remission (CR)
Time Frame: From date of randomization until the date of first documented progression whichever came first, assessed up to 84months
Percentage of participants with CR, as defined by the IMWG criteria, will be reported.
From date of randomization until the date of first documented progression whichever came first, assessed up to 84months
Very good partial response (VGPR) or better.
Time Frame: From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
VGPR or better, defined as VGPR or CR according to the IMWG criteria during or after the study treatment at the time of data cutoff.
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Overall response (CR + VGPR + partial response [PR]).
Time Frame: From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Overall response, defined as CR or VGPR or PR, according to the IMWG criteria
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Occurrence of grade 3 or more side effects.
Time Frame: From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Collecting all AE (grade 3 or more)
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Safety and tolerability of Daratumumab SC when administered in combination with Revlimid: NCI-CTCAE V5.0.
Time Frame: From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Evaluation of safety data by type, frequency, severity, relation to study drug, according to NCI-CTCAE V5.0.
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Evaluation of quality of life based on MY20 questionnaires
Time Frame: From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Treatment effects on patient reported outcomes and heath economic/resource utilization.
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Evaluation of quality of life based on EORTC C30 questionnaires
Time Frame: From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Treatment effects on patient reported outcomes and heath economic/resource utilization.
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Evaluation of quality of life based on EQ-5D questionnaires
Time Frame: From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Treatment effects on patient reported outcomes and heath economic/resource utilization.
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Minimal residual disease (MRD) negative rate at 12 months.
Time Frame: after 12 months of treatment
Proportion of participants assessed as MRD negative
after 12 months of treatment
Event Free Survival
Time Frame: From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thierry Facon, MD,PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 7, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018_16
  • 2018-003535-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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