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Multiple MyelomaPhase 3EMN14NCT03180736

Comparison of Pom and Dex in Subjects With RRMM Previously Treated With Len and a PI Dara/Pom/Dex vs Pom/Dex

A Phase 3 study testing Daratumumab, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Stichting European Myeloma Network at 40 sites in 10 countries.

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

The purpose of this study is to evaluate the effects of the addition of daratumumab to pomalidomide and dexamethasone in terms of progression-free survival in subjects with relapsed or refractory Multiple Myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Daratumumab, Pomalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
40 sitesin 10 countries
Study dates
14 Jun 2017to 30 Nov 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females at least 18 years of age.
  • Voluntary written informed consent before performance of any study-related procedure.
  • Subject must have measurable disease of MM as defined by the criteria below:
  • IgG multiple myeloma: Serum M protein level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours, or
  • IgA, IgD, IgE, IgM multiple myeloma: Serum M-protein level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
  • Light chain multiple myeloma, for subjects without measurable disease in the serum or urine: Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
Show all 31Show fewer
  • Subjects must have received prior antimyeloma treatment. The prior treatment must have included both a PI- and lenalidomide-containing regimens. The subject must have had a response (ie, PR or better based on the investigator's determination of response as defined by the modified IMWG criteria) to prior therapy.
  • Subjects must have documented evidence of PD based on the investigator's determination of response as defined by the modified IMWG criteria on or after the last regimen.
  • Subjects who received only 1 line of prior treatment must have demonstrated PD on or within 60 days of completion of the lenalidomide containing regimen (ie, lenalidomide refractory).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.
  • Willingness and ability to participate in study procedures.
  • For subjects experiencing toxicities resulting from previous therapy, the toxicities must be resolved or stabilized to ≤Grade 1.
  • Any of the following laboratory test results during Screening:
  • Absolute neutrophil count ≥1.0 × 109/L;
  • Hemoglobin level ≥7.5 g/dL (≥4.65 mmol/L); (transfusions are not permitted to reach this level);
  • Platelet count ≥75 × 109/L in subjects in whom <50% of bone marrow nucleated cells are plasma cells and platelet count ≥50 x 109/L in subjects in whom ≥50% of bone marrow nucleated cells are plasma cells;
  • Alanine aminotransferase (ALT) level ≤2.5 times the upper limit of normal (ULN);
  • Aspartate aminotransferase (AST) level ≤2.5 x ULN;
  • Total bilirubin level ≤1.5 x ULN, (except for Gilbert Syndrome: direct bilirubin ≤1.5 × ULN);
  • Creatinine clearance ≥30 mL/min
  • Serum calcium corrected for albumin ≤14.0 mg/dL (≤3.5 mmol/L), or free ionized calcium ≤ 6.5 mg/dL (≤1.6 mmol/L).
  • Reproductive Status
  • Women of childbearing potential (WOCBP) must have 2 negative serum or urine pregnancy tests, one 10-14 days prior to start of study treatment and one 24 hours prior to the start of study treatment. Females are not of reproductive potential if they have been in natural menopause for at least 24 consecutive months, or have had a hysterectomy and/or bilateral oophorectomy.
  • Women must not be breastfeeding.
  • WOCBP must agree to follow instructions for methods of contraception for 4 weeks before the start of study treatment, for the duration of study treatment, and for 3 months after cessation of daratumumab or 4 weeks after cessation of pomalidomide, whichever is longer.
  • Males who are sexually active must always use a latex or synthetic condom during any sexual contact with females of reproductive potential, even if they have undergone a successful vasectomy. They must also agree to follow instructions for methods of contraception for 4 weeks before the start of study treatment, for the duration of study treatment, and for a total of 3 months post-treatment completion.
  • Male subjects must not donate sperm for up to 90 days post-treatment completion.
  • Female subject must not donate eggs for up to 90 days post-treatment completion.
  • Azoospermic males and WOCBP who are not heterosexually active are exempt from contraceptive requirements. However, WOCBP will still undergo pregnancy testing as described in this section.
  • Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly. Subjects must agree to the use of 2 methods of contraception, with 1 method being highly effective and the other method being additionally effective.
  • Because of the embryo-fetal risk of pomalidomide, all subjects must adhere to the pomalidomide pregnancy prevention program applicable in their region. Investigators should comply with the local label for pomalidomide for specific details of the program.

Who cannot join

  • Previous therapy with any anti-CD38 monoclonal antibody.
  • Previous exposure to pomalidomide.
  • Subject has received antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) for palliative treatment before Cycle 1, Day 1 (C1D1).
  • Previous allogenic stem cell transplant; or autologous stem cell transplantation (ASCT) within 12 weeks before C1D1.
  • History of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years).
  • Clinical signs of meningeal involvement of MM.
Show all 20Show fewer
  • Chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for subjects suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal.
  • Clinically significant cardiac disease, including:
  • Myocardial infarction within 6 months, before C1D1 or unstable or uncontrolled condition (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV).
  • Cardiac arrhythmia (Common Terminology Criteria for Adverse Events [CTCAE] Grade 3 or higher) or clinically significant electrocardiogram (ECG) abnormalities.
  • Electrocardiogram showing a baseline QT interval as corrected QTc >470 msec.
  • Known active hepatitis A, B, or C.
  • Known HIV infection.
  • Gastrointestinal disease that may significantly alter the absorption of pomalidomide.
  • Subject has plasma cell leukemia (>2.0 × 109/L circulating plasma cells by standard differential) or Waldenström's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.
  • Any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary 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.
  • Ongoing ≥ Grade 2 peripheral neuropathy.
  • Subject had ≥Grade 3 rash during prior therapy.
  • Subject has had major surgery within 2 weeks before randomization, or has not fully recovered from an earlier surgery, or has surgery planned during the time the subject is expected to participate in the study or within 2 weeks after the last dose of study drug administration. Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery.
  • Pregnant or nursing women.

Trial locations and contacts

40 sites in 10 countries.

40 sites in 10 countries

Germany7 sites

  • Freiburg

    Freiburg im Breisgau

  • Hamburg

    Hamburg

  • Heidelberg

    Heidelberg

  • Kiel

    Kiel

  • Schwerin

    Schwerin

  • Tübingen

    Tübingen

  • Würzburg

    Würzburg

Other trials in Germany

Italy6 sites

  • Ancona

    Ancona

  • Bologna

    Bologna

  • Brescia

    Brescia

  • Milano

    Milan

  • Roma

    Roma

  • Torino

    Torino

Other trials in Italy

Spain6 sites

  • Badalona

    Badalona

  • Barcelona

    Barcelona

  • Hospital Quirón Salud Madrid

    Madrid

  • Hospital Universitario de la Princesa

    Madrid

  • Salamanca University Hospital

    Salamanca

  • Doctor Peset University Hospital Medical Centre

    Valencia

Other trials in Spain

Turkey (Türkiye)5 sites

  • Capa

    Çapa

  • Cebeci

    Cebeli

  • Gaziantep

    Gaziantep

  • Izmir

    Izmir

  • Kayseri

    Kayseri

Other trials in Turkey (Türkiye)

Belgium4 sites

  • Antwerpen

    Antwerp

  • Brussel

    Brussels

  • UZ Gent

    Ghent

  • Yvoir

    Yvoir

Other trials in Belgium

Greece4 sites

  • General Hospital of Athens "Evangelismos"

    Athens

  • University of Athens School of Medicine

    Athens

  • General University Hospital of Patras

    Pátrai

  • Anticancer Hospital of Thessaloniki "Theageneio"

    Thessaloniki

Other trials in Greece

Czechia3 sites

  • Brno

    Brno

  • Ostrava

    Ostrava

  • Praha 2

    Prague

Other trials in Czechia

Denmark2 sites

  • Odense

    Odense

  • Vejle

    Vejle

Other trials in Denmark

Netherlands2 sites

  • VU MC

    Amsterdam

  • Erasmus MC

    Rotterdam

Other trials in Netherlands

Serbia1 site

  • Belgrade

    Belgrade

Other trials in Serbia

About this study

Official title: A Phase 3 Study Comparing Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With RRMM Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor.

The purpose of this study is to evaluate the effects of the addition of daratumumab to pomalidomide and dexamethasone in terms of progression-free survival in subjects with relapsed or refractory Multiple Myeloma.

Read the detailed description

This is a multicenter, Phase 3, randomized, open-label study comparing daratumumab, pomalidomide and low-dose dexamethasone (DaraPomDex) with pomalidomide and low-dose dexamethasone (PomDex) in subjects with relapsed or refractory Multiple Myeloma who have received at least 1 prior treatment regimen with both lenalidomide and a proteasome inhibitor and have demonstrated disease progression. Subjects will be randomized in a 1:1 ratio to receive either DaraPomDex or PomDex. The original design of this study was to treat subjects with daratumumab for intravenous (IV) infusion (Dara IV); however, as of Amendment 1, all new subjects will be dosed subcutaneously with daratumumab co-formulated with recombinant human hyaluronidase rHuPH20 (hereafter referred to as Dara SC). Subjects who already began treatment with Dara IV (ie, prior to Amendment 1) will have the option to switch to Dara SC on Day 1 of any cycle starting with Cycle 3 or later for the remainder of their participation in the study, and they will be counted toward the total of 302 subjects. Subjects will receive treatment until disease progression or unacceptable toxicity. Drug administration and follow-up visits will occur more frequently for early cycles (e.g., weekly or bi-weekly). Disease evaluations will occur every cycle and consist mainly of measurements of myeloma proteins. Subject safety will be assessed throughout the study. The primary endpoint will be progression-free survival (PFS). Study end is anticipated at approximately 5 years after the last subject is randomized.

Medical subject headings
Multiple Myeloma

What participants receive

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

  • DaratumumabDrug

    Also called Dara

    Daratumumab will be given at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs.

  • PomalidomideDrug

    Also called Pom

    Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.

  • DexamethasoneDrug

    Also called Dex

    Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.

Study groups in NCT03180736
Study groupRoleWhat they receive
Daratumumab+Pomalidomide+DexamethasoneExperimentalDaratumumab at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Pomalidomide 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle Dexamethasone 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle
Receives: Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone
Pomalidomide + DexamethasoneActive comparatorPomalidomide 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle Dexamethasone 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle
Receives: Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

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

  1. Comparison of Progression Free Survival Between Treatment Arms (Daratumumab /Pomalidomide /Dexamethasone vs Pomalidomide / Dexamethasone)

    Progression Free Survival (PFS) is defined as the time, in months, from randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever comes first.

    PFS2 is defined as the time, in months, from randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever comes first, after the next line of therapy.

    PD is assessed by the investigator based on the analysis of serum and urine protein electrophoresis (sPEP and uPEP), serum and urine immunofixation (sIFE and uIFE), serum free light chain protein (sFLC),corrected serum calcium assessment, imaging and bone marrow assessments as per modified IMWG guidelines.

    Measured: PFS is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 3 years). PFS2 is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 5 years).

Secondary outcomes (8)

  1. Overall Response Rate

    Overall response rate is defined as the proportion of randomized participants who achieved a best response of PR or better using modified IMWG criteria.

    Measured: Approximately up to 3 years (assessed monthly from randomization until PD).

  2. Depth of Response

    Depth of response is the analysis of the Minimal Residual Disease (MRD) negativity rate at the sensitivity threshold of 10^-5 for patients who have achieved CR or better and for patients with suspected CR/sCR.

    Measured: MRD is assessed at the time of suspected CR/sCR and 6, 12, 18, 24, and every 12 months (yearly assessments ±3 months) post CR/sCR in subjects who maintain CR. or sCR, until PD.

  3. Duration of Response

    Duration of response will be restricted to the randomized subjects who achieve a best objective response of PR or better. It is measured from the time, in months, that the criteria for objective response are first met until the date of a progression event (according to the primary definition of PFS).

    Measured: From informed consent until 30 days after last study treatment, assessed up to approximately 3 years.

  4. Time to Next Therapy

    Time to next therapy will be defined as the time, in months, from randomization to the date to next anti-neoplastic therapy or death from any cause, whichever comes first.

    Measured: From randomization until the date to next anti-neoplastic therapy or death from any cause, whichever comes first (approximately up to 3 years)

  5. Overall Survival

    Overall survival is defined as the time, in months, from randomization to the date of death from any cause.

    Measured: From randomization until death from any cause (up to 5 years)

  6. Health-related Quality of Life-Time to Worsening in EORTC QLQ-C30 Scale Scores

    Worsening is defined as a decrease in score that is at least half of standard deviation from baseline values, where standard deviation is calculated from the scores at baseline combining both treatment groups.

    Measured: Approximately up to 3 years (assessed on Day 1 of each treatment cycle, at the end of treatment, and every 4 weeks post treatment until PD.

  7. Health-related Quality of Life-Time to Worsening in EQ-5D-5L Utility Score

    Worsening is defined as a decrease in score that is at least half of standard deviation from baseline values, where standard deviation is calculated from the scores at baseline combining both treatment groups.

    The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today"

    Measured: Approximately up to 3 years (assessed on Day 1 of each treatment cycle, at the end of treatment, and every 4 weeks post treatment until PD).

  8. Health-related Quality of Life-Time to Worsening in EQ-5D-5L Visual Analogue Scale

    Worsening is defined as a decrease in score that is at least half of standard deviation from baseline values, where standard deviation is calculated from the scores at baseline combining both treatment groups.

    The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today"

    Measured: Approximately up to 3 years (assessed on Day 1 of each treatment cycle, at the end of treatment, and every 4 weeks post treatment until PD).

Timeline

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

  1. First posted8 Jun 2017
  2. Study start14 Jun 2017
  3. Primary completion21 Jul 2020
  4. Study completion30 Nov 2024

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
Model description
Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Masking
Single blind
Who is masked
Participant
Enrolment
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03180736
Sponsor's protocol ID
EMN14/54767414MMY3013
Acronym
EMN14
Status last verified
Dec 2024
First submitted
30 May 2017
Last updated
19 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dimopoulos MA, Terpos E, Boccadoro M, Delimpasi S, Beksac M, Katodritou E, Moreau P, Baldini L, Symeonidis A, Bila J, Oriol A, Mateos MV, Einsele H, Orfanidis I, Kampfenkel T, Liu W, Wang J, Kosh M, Tran N, Carson R, Sonneveld P. Subcutaneous daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (APOLLO): extended follow up of an open-label, randomised, multicentre, phase 3 trial. Lancet Haematol. 2023 Oct;10(10):e813-e824. doi: 10.1016/S2352-3026(23)00218-1.

    PubMed 37793772

  • He J, Berringer H, Heeg B, Ruan H, Kampfenkel T, Dwarakanathan HR, Johnston S, Mendes J, Lam A, Bathija S, Mackay EK. Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma. Adv Ther. 2022 Sep;39(9):4230-4249. doi: 10.1007/s12325-022-02226-x. Epub 2022 Jul 22.

    PubMed 35876974

  • Dimopoulos MA, Terpos E, Boccadoro M, Delimpasi S, Beksac M, Katodritou E, Moreau P, Baldini L, Symeonidis A, Bila J, Oriol A, Mateos MV, Einsele H, Orfanidis I, Ahmadi T, Ukropec J, Kampfenkel T, Schecter JM, Qiu Y, Amin H, Vermeulen J, Carson R, Sonneveld P; APOLLO Trial Investigators. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Jun;22(6):801-812. doi: 10.1016/S1470-2045(21)00128-5.

    PubMed 34087126

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daratumumab, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Stichting European Myeloma Network at 40 sites in 10 countries.

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 31 inclusion and 20 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Germany, Italy, Spain, Turkey (Türkiye), Belgium and 5 more countries. 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 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?

Yes. Results are posted in the registry (first posted 11 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Progression Free Survival Between Treatment Arms (Daratumumab /Pomalidomide /Dexamethasone vs Pomalidomide / Dexamethasone) (time frame: PFS is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 3 years). PFS2 is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 5 years).). 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 NCT03180736, which also lists 3 linked publications.

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 19 Dec 2025.

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