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Multiple MyelomaPhase 3IFM2017_03NCT03993912

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

A Phase 3 study testing Daratumumab SC in combination with Lenalidomide, Lenalidomide PO (25mg) and Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression in people with Multiple Myeloma, run by University Hospital, Lille at 23 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… 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?
Daratumumab SC in combination with Lenalidomide, Lenalidomide PO (25mg) and Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
294 participants
Where
23 sitesFrance
Study dates
17 Oct 2019to 28 Aug 2026
Phase
Phase 3
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

  • Subject must be at least 65 years of age.
  • Subject must have documented multiple myeloma satisfying the CRAB criteria and measurable disease.
  • Newly diagnosed and not considered candidate for high-dose chemotherapy with SCT.
  • Subject must have a Frailty Score ≥ 2
  • 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
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  • 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
  • Measurable ISS with β2-microglobulin and albumin values for randomization
  • 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.
  • 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.
  • Subjects affiliated with an appropriate social security system.

Who cannot join

  • Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma.
  • 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.
  • Subject has prior or current systemic therapy or SCT for multiple myeloma
  • Subject has a history of malignancy (other than multiple myeloma) within 5 years before the date of randomization
  • Subject has had radiation therapy within 14 days of randomization.
  • Subject has had plasmapheresis within 28 days of randomization.
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  • Subject is exhibiting clinical signs of meningeal involvement of multiple myeloma.
  • 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).
  • Subject is known to be seropositive for history of human immunodeficiency virus (HIV)
  • Seropositive for hepatitis B.
  • (Known to be) seropositive for hepatitis C
  • 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.
  • 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
  • Subject has known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients
  • Subject has plasma cell leukemia or POEMS syndrome
  • 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.
  • Subject has had major surgery within 2 weeks before randomization or has not fully recovered from surgery.
  • 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.
  • Refusal to consent or protected by legal regime ( guardianship, trusteeship)
  • Subject has contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism
  • Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

France23 sites

  • Chru Jean Minjoz

    Besançon

  • Ch Blois Simone Veil

    Blois

  • Ch Fleyriat

    Bourg-en-Bresse

  • Chru Brest Site Hopital Morvan

    Brest

  • Chu de Caen Normandie

    Caen

  • Hopital Prive Sevigne - Cesson

    Cesson-Sévigné

  • Chu Dijon Bourgogne

    Dijon

  • Chu de Grenoble

    Grenoble

  • Gpe Hospitalier La Rochelle-Re-Aunis

    La Rochelle

  • Ch Chartres Louis Pasteur-Le Coudray

    Le Coudray

  • Hôpital Claude Huriez, CHU

    Lille

  • Institut Paoli Calmettes

    Marseille

  • Chi Mont de Marsan Et Pays Des Sources

    Mont-de-Marsan

  • Chu Montpellier

    Montpellier

  • Chu de Nantes Site Hotel Dieu Hme

    Nantes

  • Chu de Nice Hopital de L'Archet

    Nice

  • Centre Hospitalier de Perigueux

    Périgueux

  • Hopital Haut-Leveque - Chu

    Pessac, 33604

  • Chru Rennes Site Pontchaillou

    Rennes

  • Centre Hospitalier de Saint Quentin

    Saint-Quentin

  • Centre Hospitalier Saint-Malo

    St-Malo

  • Oncopole Chu Toulouse

    Toulouse

  • Chu de Tours

    Tours

Other trials in France

About this study

Official title: 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

Read the 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

Being tested
Daratumumab SC in combination with Lenalidomide, Lenalidomide PO (25mg), Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression
Keywords
Newly diagnosed Multiple Myeloma, Frail elderly patients, Dexamethasone-sparing regimen, Daratumumab, Toxicity
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daratumumab SC in combination with LenalidomideDrug

    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)Drug

    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 progressionDrug

    Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression

Study groups in NCT03993912
Study groupRoleWhat they receive
Arm 1: Experimental groupExperimentalDaratumumab 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
Receives: Drug: Daratumumab SC in combination with Lenalidomide; Drug: Lenalidomide PO (25mg); Drug: Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression
Arm 2: Control groupSham comparatorLenalidomide 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
Receives: Drug: Lenalidomide PO (25mg); Drug: Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of the efficacy of Daratumumab SC injection when combined with Lenalidomide (R-Dara SC) vs Lenalidomide and Dexamethasone (Rd): PFS

    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.

    Measured: 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 outcomes (14)

  1. Time-to-treatment failure

    Measured: 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

  2. Time-to-next treatment

    Measured: 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

  3. PFS2 time

    Measured: 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

  4. Overall survival (OS) time

    Overall survival (OS) time,

    Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 84months

  5. Complete remission (CR)

    Percentage of participants with CR, as defined by the IMWG criteria, will be reported.

    Measured: From date of randomization until the date of first documented progression whichever came first, assessed up to 84months

  6. Very good partial response (VGPR) or better.

    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.

    Measured: 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

  7. Overall response (CR + VGPR + partial response [PR]).

    Overall response, defined as CR or VGPR or PR, according to the IMWG criteria

    Measured: 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

  8. Occurrence of grade 3 or more side effects.

    Collecting all AE (grade 3 or more)

    Measured: 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

  9. Safety and tolerability of Daratumumab SC when administered in combination with Revlimid: NCI-CTCAE V5.0.

    Evaluation of safety data by type, frequency, severity, relation to study drug, according to NCI-CTCAE V5.0.

    Measured: 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

  10. Evaluation of quality of life based on MY20 questionnaires

    Treatment effects on patient reported outcomes and heath economic/resource utilization.

    Measured: 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

  11. Evaluation of quality of life based on EORTC C30 questionnaires

    Treatment effects on patient reported outcomes and heath economic/resource utilization.

    Measured: 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

  12. Evaluation of quality of life based on EQ-5D questionnaires

    Treatment effects on patient reported outcomes and heath economic/resource utilization.

    Measured: 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

  13. Minimal residual disease (MRD) negative rate at 12 months.

    Proportion of participants assessed as MRD negative

    Measured: after 12 months of treatment

  14. Event Free Survival

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2019
  2. Study start17 Oct 2019
  3. Primary completion28 Aug 2026
  4. Study completion28 Aug 2026

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
294 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03993912
Sponsor's protocol ID
2018_16
Other IDs
2018-003535-30, 2018
Acronym
IFM2017_03
Status last verified
Sep 2026
First submitted
27 May 2019
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Manier S, Lambert J, Hulin C, Macro M, Laribi K, Araujo C, Pica GM, Touzeau C, Godmer P, Slama B, Karlin L, Orsini Piocelle F, Dib M, Sanhes L, Morel P, El Yamani A, Tiab M, Tabrizi R, Richez V, Garderet L, Royer B, Bareau B, Mariette C, Fleck E, Robu D, Calmettes C, Rigaudeau S, Demarquette H, Frenzel L, Decaux O, Mohty M, Arnulf B, Bigot N, Perrot A, Corre J, Mary JY, Avet-Loiseau H, Moreau P, Leleu X, Facon T. Safety and efficacy of a dexamethasone-sparing regimen with daratumumab and lenalidomide in patients with frailty and newly diagnosed multiple myeloma (IFM2017-03): a phase 3, open-label, multicentre, randomised, controlled trial. Lancet Oncol. 2025 Oct;26(10):1323-1333. doi: 10.1016/S1470-2045(25)00280-3.

    PubMed 41038184

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daratumumab SC in combination with Lenalidomide, Lenalidomide PO (25mg) and Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression in people with Multiple Myeloma, run by University Hospital, Lille at 23 sites in France.

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 16 inclusion and 24 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: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03993912, which also lists 1 linked publication.

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 23 Sep 2026.

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