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Multiple MyelomaPhase 1NCT01998971

A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma

A Phase 1 study testing Daratumumab, Velcade and Pomalidomide in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 22 sites in 3 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of 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, Velcade and Pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
22 sitesin 3 countries
Study dates
18 Feb 2014to 11 Jan 2024
Phase
Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of symptomatic multiple myeloma and measurable secretory disease
  • For carfilzomib-lenalidomide-dexamethasone (KRd) regimen: newly diagnosed myeloma. For carfilzomib-dexamethasone (CFZ-dex) regimen: relapsed or refractory disease
  • Eastern Cooperative Oncology Group performance status score of 0, 1, or 2
  • Pretreatment clinical laboratory values must meet protocol-defined parameters during the screening phase

Who cannot join

  • Previously received daratumumab or other anti-CD38 therapies
  • Diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, 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
  • Peripheral neuropathy or neuropathic pain Grade 2 or higher
  • Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of study start
  • Exhibiting clinical signs of meningeal involvement of multiple myeloma
  • Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 2 years
Show all 10Show fewer
  • Seropositive for human immunodeficiency virus, hepatitis B, or hepatitis C
  • 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
  • Clinically significant cardiac disease
  • Plasma cell leukemia or POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome

Trial locations and contacts

22 sites in 3 countries.

22 sites in 3 countries

United States10 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Boston, Massachusetts

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Dallas, Texas

  • Study site

    Duarte, California

  • Study site

    Indianapolis, Indiana

  • Study site

    New York, New York

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Rochester, New York

Other trials in United States

France6 sites

  • Study site

    Lille

  • Study site

    Nantes

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Toulouse

  • Study site

    Tours

Other trials in France

Spain6 sites

  • Study site

    Badalona

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Pamplona

  • Study site

    Salamanca

  • Study site

    Valencia

Other trials in Spain

About this study

Official title: An Open-Label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Regimens for the Treatment of Subjects With Multiple Myeloma

The purpose of this study is to evaluate the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of multiple myeloma.

Read the detailed description

This is an open-label (identity of assigned study drug will be known) study to evaluate the safety, tolerability, and dose of daratumumab when administered in combination with various treatment regimens for different settings of multiple myeloma. The various treatment regimens to be combined with daratumumab in this study include Velcade-dexamethasone (VD), Velcade-melphalan-prednisone (VMP), Velcade-thalidomide-dexamethasone (VTD), pomalidomide-dexamethasone (Pom-dex), carfilzomib-dexamethasone (CFZ-dex) and carfilzomib-lenalidomide-dexamethasone (KRd). Approximately 250 patients (approximately 12 participants per VTD and VMP backbone treatment regimen, 6 for the VD regimen, up to 100 participants in the Pom-dex regimen, 80 for the CFZ-dex regimen [10 participants will receive a single-dose of daratumumab and the remaining participants will receive a split-dose of daratumumab], and up to 40 for the KRd regimen) will be enrolled in this study. The study will consist of screening, treatment, and follow-up phases. Treatment will extend to either the planned treatment duration for a maximum of 1 year (in Velcade-dexamethasone, Velcade-melphalan-prednisone, Velcade-thalidomide-dexamethasone regimens and KRd regimens), or in the Pom-dex and CFZ-dex regimens, until disease progression, unacceptable toxicity, or until the end of study. Follow-up will continue until the study ends (approximately 25 months after the last patient receives the first dose of daratumumab). Serial pharmacokinetic (study of what a drug does to the body) blood samples will be collected. Clinical efficacy outcomes and safety will be monitored throughout the study.

Keywords
Multiple myeloma, Daratumumab, JNJ-54767414, Velcade-dexamethasone, Velcade-melphalan-prednisone, Velcade-thalidomide-dexamethasone, Pomalidomide-dexamethasone, Carfilzomib-dexamethasone, Carfilzomib-lenalidomide-dexamethasone, Anti-CD38 Monoclonal Antibody, Immunomodulatory drug, IMiD
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

    Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.

  • VelcadeDrug

    Administered subcutaneously in accordance with product labeling and local standards.

  • PomalidomideDrug

    Administered orally in accordance with product labeling and local standards.

  • DexamethasoneDrug

    Administered intravenously or orally in accordance with product labeling and local standards.

  • MelphalanDrug

    Administered orally in accordance with product labeling and local standards.

  • PrednisoneDrug

    Administered intravenously or orally in accordance with product labeling and local standards.

  • ThalidomideDrug

    Administered orally in accordance with product labeling and local standards.

  • DiphenhydramineDrug

    Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.

  • AcetaminophenDrug

    Administered in prophylactic doses by mouth in accordance with product labeling and local standards.

  • CarfilzomibDrug

    Administered intravenously in accordance with product labeling and local standards.

  • LenalidomideDrug

    Administered orally in accordance with product labeling and local standards.

  • MontelukastDrug

    Administered intravenously or orally only with the first daratumumab dose in accordance with product labeling and local standards.

Study groups in NCT01998971
Study groupRoleWhat they receive
Daratumumab + VDExperimentalDaratumumab will be administered with Velcade-dexamethasone (VD).
Receives: Drug: Daratumumab; Drug: Velcade; Drug: Dexamethasone; Drug: Diphenhydramine; Drug: Acetaminophen
Daratumumab + VMPExperimentalDaratumumab will be administered with Velcade-melphalan-prednisone (VMP).
Receives: Drug: Daratumumab; Drug: Velcade; Drug: Melphalan; Drug: Prednisone; Drug: Diphenhydramine; Drug: Acetaminophen
Daratumumab + VTDExperimentalDaratumumab will be administered with Velcade-thalidomide-dexamethasone (VTD).
Receives: Drug: Daratumumab; Drug: Velcade; Drug: Dexamethasone; Drug: Thalidomide; Drug: Diphenhydramine; Drug: Acetaminophen
Daratumumab + Pom-dexExperimentalDaratumumab will be administered with pomalidomide-dexamethasone (Pom-dex).
Receives: Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Diphenhydramine; Drug: Acetaminophen
Daratumumab + CFZ-dexExperimentalDaratumumab will be administered with carfilzomib (CFZ)-dexamethasone (CFZ-dex) regimen.
Receives: Drug: Daratumumab; Drug: Dexamethasone; Drug: Diphenhydramine; Drug: Acetaminophen; Drug: Carfilzomib; Drug: Montelukast
Daratumumab + KRdExperimentalDaratumumab will be administered with carfilzomib- lenalidomide-dexamethasone (KRd) regimen.
Receives: Drug: Daratumumab; Drug: Dexamethasone; Drug: Diphenhydramine; Drug: Acetaminophen; Drug: Carfilzomib; Drug: Lenalidomide; Drug: Montelukast

What is being measured

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

  1. Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)

    Measured: Up to 30 days after the last dose of study medication

  2. Number of participants affected by dose-limiting toxicities

    Measured: Up to 30 days after the last dose of study medication

Secondary outcomes (5)

  1. Maximum observed concentration of daratumumab

    Measured: Up to post-treatment visit Week 9

  2. Number of participants with generation of antibodies to daratumumab

    Measured: Up to post-treatment visit Week 9

  3. Complete response rate

    Measured: Up to 25 months after last patient receives first dose of study drug

  4. Overall response rate

    Measured: Up to 25 months after last patient receives first dose of study drug

  5. Duration of response

    Measured: Up to 25 months after last patient receives first dose of study drug

Timeline

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

  1. First posted3 Dec 2013 (estimated)
  2. Study start18 Feb 2014
  3. Primary completion31 Jan 2019
  4. Study completion11 Jan 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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01998971
Sponsor's protocol ID
CR103015
Other IDs
54767414MMY1001, 2013-003491-12
Status last verified
Apr 2025
First submitted
25 Nov 2013
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • Moreau P, Chari A, Oriol A, Martinez-Lopez J, Haenel M, Touzeau C, Ailawadhi S, Besemer B, de la Rubia Comos J, Encinas C, Mateos MV, Salwender H, Rodriguez-Otero P, Hulin C, Karlin L, Sureda Balari A, Bargay J, Benboubker L, Rosinol L, Tarantolo S, Terebelo H, Yang S, Wang J, Nnane I, Qi M, Kosh M, Delioukina M, Goldschmidt H. Daratumumab, carfilzomib, and dexamethasone in relapsed or refractory myeloma: final analysis of PLEIADES and EQUULEUS. Blood Cancer J. 2023 Mar 7;13(1):33. doi: 10.1038/s41408-023-00805-x. No abstract available.

    PubMed 36882409

  • 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

  • Leleu X, Beksac M, Chou T, Dimopoulos M, Yoon SS, Prince HM, Pour L, Shelekhova T, Chari A, Khurana M, Zhang J, Obreja M, Qi M, Oriol A, Siegel D. Efficacy and safety of weekly carfilzomib (70 mg/m2), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies. Leuk Lymphoma. 2021 Feb;62(2):358-367. doi: 10.1080/10428194.2020.1832672. Epub 2020 Oct 28.

    PubMed 33112184

  • Xu XS, Moreau P, Usmani SZ, Lonial S, Jakubowiak A, Oriol A, Krishnan A, Blade J, Luo M, Sun YN, Zhou H, Nnane I, Deraedt W, Qi M, Ukropec J, Clemens PL. Split First Dose Administration of Intravenous Daratumumab for the Treatment of Multiple Myeloma (MM): Clinical and Population Pharmacokinetic Analyses. Adv Ther. 2020 Apr;37(4):1464-1478. doi: 10.1007/s12325-020-01247-8. Epub 2020 Feb 20.

    PubMed 32078124

  • Chari A, Martinez-Lopez J, Mateos MV, Blade J, Benboubker L, Oriol A, Arnulf B, Rodriguez-Otero P, Pineiro L, Jakubowiak A, de Boer C, Wang J, Clemens PL, Ukropec J, Schecter J, Lonial S, Moreau P. Daratumumab plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood. 2019 Aug 1;134(5):421-431. doi: 10.1182/blood.2019000722. Epub 2019 May 21.

    PubMed 31113777

  • Chari A, Suvannasankha A, Fay JW, Arnulf B, Kaufman JL, Ifthikharuddin JJ, Weiss BM, Krishnan A, Lentzsch S, Comenzo R, Wang J, Nottage K, Chiu C, Khokhar NZ, Ahmadi T, Lonial S. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood. 2017 Aug 24;130(8):974-981. doi: 10.1182/blood-2017-05-785246. Epub 2017 Jun 21.

    PubMed 28637662

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Daratumumab, Velcade and Pomalidomide in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 22 sites in 3 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 4 inclusion and 10 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 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, France, Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT) (time frame: Up to 30 days after the last dose of study medication). The study lists 2 primary outcomes in all. 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 NCT01998971, which also lists 6 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 25 Apr 2025.

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