Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04722146
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Teclistamab Drug: Daratumumab Drug: Pomalidomide Drug: Lenalidomide Drug: Bortezomib Drug: Nirogacestat Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Actual Study Start Date : January 21, 2021
Estimated Primary Completion Date : January 26, 2022
Estimated Study Completion Date : November 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide
Participants will receive teclistamab plus daratumumab plus pomalidomide.
Drug: Teclistamab
Participants will receive teclistamab.
Other Name: JNJ-64007957

Drug: Daratumumab
Participants will receive daratumumab.

Drug: Pomalidomide
Participants will receive pomalidomide.

Experimental: Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib.
Drug: Teclistamab
Participants will receive teclistamab.
Other Name: JNJ-64007957

Drug: Daratumumab
Participants will receive daratumumab.

Drug: Lenalidomide
Participants will receive lenalidomide.

Drug: Bortezomib
Participants will receive bortezomib.

Experimental: Treatment Regimen C: Teclistamab + Nirogacestat
Participants will receive teclistamab plus nirogacestat.
Drug: Teclistamab
Participants will receive teclistamab.
Other Name: JNJ-64007957

Drug: Nirogacestat
Participants will receive nirogacestat.




Primary Outcome Measures :
  1. Number of Participants with Incidence of Adverse Events (AEs) [ Time Frame: Up to 53 weeks ]
    An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.

  2. Number of Participants with AEs by Severity [ Time Frame: Up to 53 weeks ]
    Number of participants with AEs by severity will be reported.

  3. Number of Participants with Abnormalities in Laboratory Values [ Time Frame: Up to 53 weeks ]
    Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.

  4. Number of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: Up to Cycle 2 Day 15 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B) ]
    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.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 53 weeks ]
    ORR is defined as the proportion of participants who achieve partial response (PR) or better according to the international myeloma working group (IMWG) 2016 criteria.

  2. Very Good Partial Response (VGPR) or Better Response Rate [ Time Frame: Up to 53 weeks ]
    VGPR or better response rate is defined as the proportion of participants who achieve a VGPR or better response (stringent complete response [sCR]+ complete response [CR]+VGPR) according to the IMWG 2016 criteria.

  3. Complete Response (CR) or Better Response Rate [ Time Frame: Up to 53 weeks ]
    CR or better response rate is defined as the proportion of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.

  4. Stringent Complete Response (sCR) Rate [ Time Frame: Up to 53 weeks ]
    sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria.

  5. Duration of Response [ Time Frame: Up to 53 weeks ]
    Duration of response is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria.

  6. Time to Response [ Time Frame: Up to 53 weeks ]
    Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better.

  7. Serum Concentrations of Teclistamab [ Time Frame: Up to 53 weeks ]
    Serum concentrations of teclistamab will be reported.

  8. Serum Concentrations of Daratumumab [ Time Frame: Up to 53 weeks ]
    Serum concentrations of daratumumab will be reported.

  9. Serum Concentrations of Nirogacestat [ Time Frame: Up to 53 weeks ]
    Serum concentration of nirogacestat will be reported.

  10. Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab [ Time Frame: Up to 53 weeks ]
    Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens.

  11. Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab [ Time Frame: Up to 53 weeks ]
    Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A and Treatment Regimen B.

  12. Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) [ Time Frame: Up to 53 weeks ]
    Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A and Treatment Regimen B.



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.


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

Inclusion Criteria:

  • Have documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
  • Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab [tec]-daratumumab [dara]-pomalidomide [pom]) only: Participant has relapsed or refractory multiple myeloma and has received at least 1 prior line of therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment Regimen B (tec-dara-lenalidomide [len]-bortezomib [bor]) only: Participant has newly diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with lenalidomide; Treatment Regimen C (tec-nirogacestat [niro]) only: Participant has relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38 monoclonal antibody (mAb)
  • Have measurable disease at screening as defined by at least one of the following: serum M-protein level greater than or equal to (>=) 1.0 gram/deciliter (g/dL); or urine M-protein level >= 200 milligram (mg)/24 hours; or light chain multiple myeloma: serum immunoglobulin (Ig) free light chain (FLC) >=10 milligram/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
  • A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [hCG]) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 100 days after the last dose of study treatment

Exclusion Criteria:

  • Prior treatment with any therapy that targets B-cell maturation antigen (BCMA)
  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment, unless approved by sponsor
  • Received a cumulative dose of corticosteroids equivalent to >= 140 mg of prednisone within the 14-day period before the start of study treatment administration
  • Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
  • Known to be seropositive for human immunodeficiency virus

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): NCT04722146


Contacts
Layout table for location contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
Show Show 27 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Layout table for investigator information
Study Director: Janssen Research and Development, LLC Clinical Trial Janssen Research and Development LLC
Additional Information:
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04722146    
Other Study ID Numbers: CR108927
2020-004404-33 ( EudraCT Number )
64007957MMY1004 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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
Lenalidomide
Pomalidomide
Bortezomib
Daratumumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents