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Trial record 33 of 37 for:    Recruiting Studies | Multiple Myeloma | Spain | ( Map: Spain )

Dose Escalation Study of JNJ-64007957, a Humanized BCMA CD3 DuoBody® Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03145181
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for JNJ-64007957 and to characterize the safety and tolerability of JNJ-64007957 at the RP2Ds.

Condition or disease Intervention/treatment Phase
Hematological Malignancies Drug: JNJ-64007957 (IV) Drug: JNJ-64007957 (SC) Phase 1

Detailed Description:
The study will be conducted in 2 parts, separately for IV and SC administration: dose escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-64007957 administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as the last study assessment for the last participant on study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64007957, a Humanized BCMA x CD3 DuoBody® Antibody in Subjects With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : May 16, 2017
Estimated Primary Completion Date : December 14, 2019
Estimated Study Completion Date : June 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Part 1: Dose Escalation (IV)
Participants will receive intravenous (IV) infusion of JNJ-64007957 until the completion of the End of Treatment Visit.
Drug: JNJ-64007957 (IV)
Participants will receive IV infusion of JNJ-64007957.

Experimental: Part 2: Dose Expansion (IV)
Participants will receive IV infusion of JNJ-64007957 at each putative IV recommended Phase 2 doses (RP2Ds).
Drug: JNJ-64007957 (IV)
Participants will receive IV infusion of JNJ-64007957.

Experimental: Part 1: Dose Escalation (SC)
Participants will receive JNJ-64007957 subcutaneously (SC) starting at an IV dose and schedule that was deemed safe and cleared by the safety evaluation team (SET). Subsequent SC dose levels will be selected based on all available data to identify safe and tolerable putative RP2D.
Drug: JNJ-64007957 (SC)
Participants will receive SC injection of JNJ-64007957.

Experimental: Part 2: Dose Expansion (SC)
Participants may receive JNJ-64007957 SC at each putative SC RP2D.
Drug: JNJ-64007957 (SC)
Participants will receive SC injection of JNJ-64007957.




Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: Up to Day 28 ]
    The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.

  2. Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: From signing of Informed Consent Form (ICF) up to follow up (approximately up to 6 months) ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.


Secondary Outcome Measures :
  1. JNJ-64007957 Serum Concentrations [ Time Frame: Up to 8 weeks ]
    Concentration assessment will be done to evaluate the effect of JNJ-64007957.

  2. Number of Participants with JNJ-64007957 Antibodies [ Time Frame: Up to 8 weeks ]
    Antibodies to JNJ-64007957 will be assessed to evaluate potential immunogenicity.

  3. Preliminary Antitumor Activity of JNJ‑64007957 at the RP2D(s) in Part 2 [ Time Frame: Up to End of Treatment (Approximately 91 days) ]
    Preliminary antitumor activity of JNJ‑64007957 will be done using the International Myeloma Working Group (IMWG) response criteria.

  4. Biomarker Assessment [ Time Frame: Up to 8 weeks ]
    Biomarker assessment may be done to evaluate the effect of JNJ‑64007957.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Measurable multiple myeloma that is relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory multiple myeloma or be intolerant of those established multiple myeloma therapies, and a candidate for JNJ-64007957 treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitor and an immunomodulatory drug in any order during the course of treatment. Participants who could not tolerate a proteasome inhibitor or immunomodulatory drugs are allowed
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Women of childbearing potential and fertile men who are sexually active must agree to use a highly effective method of contraception (less than [<] 1 percent [%] / year failure rate) during the study and for 90 days after the last dose of study drug. Contraception must be consistent with local regulations regarding the use of birth control methods for participants participating in clinical trials. When a woman is of childbearing potential the following are required: Participants must agree to practice a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly). Examples of highly effective contraceptives for women include user-independent methods (for example, implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; vasectomized partner) and user-dependent methods (for example: combined [estrogen- and progestogen-containing] hormonal contraception associated with inhibition of ovulation [oral/intravaginal/ transdermal]; progestogen-only hormone contraception associated with inhibition of ovulation [oral/injectable]. In addition to the highly effective method of contraception, a man who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (for example a condom with spermicidal foam/gel/film/cream/suppository). Additionally, a man who is sexually active with a woman who is pregnant must use a condom. Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, during the study and for 90 days after the last dose of study drug
  • Participants must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease

Exclusion Criteria:

  • Prior treatment with any B cell maturation antigen (BCMA) targeted therapy
  • Prior antitumor therapy as follows, before the first dose of study drug: Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less; Monoclonal antibody treatment for multiple myeloma within 21 days; Cytotoxic therapy within 21 days; Proteasome inhibitor therapy within 14 days; Immunomodulatory agent therapy within 7 days; Radiotherapy within 21 days. However, if the radiation portal covered less than or equal to (<=) 5% of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy
  • Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • Received a cumulative dose of corticosteroids equivalent to greater than or equal to (>=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
  • Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145181


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
United States, Massachusetts
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215-5418
United States, New York
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects Recruiting
New York, New York, United States, 10029
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
France
Centre hospitalier Lyon-Sud Not yet recruiting
Pierre Benite cedex, France, 69495
CHRU Tours Hôpital Bretonneau Not yet recruiting
Tours, France, 37044
Netherlands
VU Medisch Centrum Recruiting
Amsterdam, Netherlands, 1081 HV
Spain
Hosp. Univ. Germans Trias I Pujol Recruiting
Badalona, Spain, 08916
Hosp. Clinic I Provincial de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Clinica Univ. de Navarra Recruiting
Pamplona, Spain, 31008
Hosp. Clinico Univ. de Salamanca Recruiting
Salamanca, Spain, 37007
Sweden
Haematology Centre, R 51 Recruiting
Stockholm, Sweden, SE-141 86
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03145181     History of Changes
Other Study ID Numbers: CR108206
2016-002122-36 ( EudraCT Number )
64007957MMY1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs