Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With

Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1)

Last Updated August 15, 2024

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CR108206

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 1

1
Sites
13 Sites
Status

Recruiting

SUMMARY

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 Teclistamab 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 2 years after the last participant in Part 3 has received his or her initial dose of teclistamab. Study record NCT04557098 is Phase 2 part of this study and study record NCT03145181 is Phase 1 part of this study.

CONDITIONS

Hematological Malignancies

ELIGIBILITY

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 Teclistamab treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory drug and anti-CD38 monoclonal antibody in any order during the course of treatment. Participants who could not tolerate a proteasome inhibitor or immunomodulatory drugs and an anti-CD38 monoclonal antibody are allowed
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
* Female participants of childbearing potential must use acceptable method of contraception
* Participants must sign an 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; Gene modified adoptive cell therapy (example, chimeric antigen receptor modified T cells, natural killer [NK] cells) within 3 months; Radiotherapy within 14 days or focal radiation within 7 days
* Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
* Received a cumulative dose of corticosteroids equivalent 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

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Spain, Sweden, France, Netherlands

Country (5)	City or Province (13)	Status
United States	Duarte City of Hope	RECRUITING
United States	Denver Colorado Blood Cancer Institute	RECRUITING
United States	New York Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects	RECRUITING
United States	Charlotte Levine Cancer Institute	RECRUITING
United States	Philadelphia University of Pennsylvania	RECRUITING
Spain	Badalona Hosp. Univ. Germans Trias I Pujol	RECRUITING
Spain	Barcelona Hosp Clinic de Barcelona	RECRUITING
Spain	Pamplona Clinica Univ. de Navarra	RECRUITING
Spain	Salamanca Hosp Clinico Univ de Salamanca	RECRUITING
Sweden	Stockholm Haematology Centre, R 51	RECRUITING
France	Pierre Benite cedex Centre hospitalier Lyon-Sud	ACTIVE_NOT_RECRUITING
France	Tours CHRU Tours Hopital Bretonneau	ACTIVE_NOT_RECRUITING
Netherlands	Amsterdam VU Medisch Centrum	ACTIVE_NOT_RECRUITING

Geo Locations

34.13945, -117.97729

39.73915, -104.9847

40.71427, -74.00597

35.22709, -80.84313

39.95233, -75.16379

41.45004, 2.24741

41.38879, 2.15899

42.81687, -1.64323

40.96882, -5.66388

59.33258, 18.0649

45.7009, 4.82511

47.38333, 0.68333

52.37403, 4.88969

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Corresponds to individual site.

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