A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Running, not enrolling · Phase 2
Conditions studied: Hematological Malignancies
In brief
The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).
Key facts
- Study ID
- NCT04557098
- Run by
- Janssen Research & Development, LLC
- People needed
- 194
- Starts
- 2020-09-17
- Expected to finish
- 2027-05-28
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
- The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (<=) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction <= 6 m, stage III-IV congestive heart failure, etc)
- Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3
- Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug
- Toxicities from previous anticancer therapies that have not resolved to baseline or to <= grade 1 (except for alopecia or peripheral neuropathy)
- Received a cumulative dose of corticosteroids equivalent to >=140 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 (MM)
- Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence
- Prior allogenic stem cell transplant <=6 months
- Prior autologous stem cell transplant <=12 weeks
- Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab
Where it is running
- City of Hope — Duarte, California, United States
- University of California San Francisco — San Francisco, California, United States
- Stanford University Medical Center — Stanford, California, United States
- Winship Cancer Institute Emory University — Atlanta, Georgia, United States
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
- Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects — New York, New York, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- Levine Cancer Institute — Charlotte, North Carolina, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Universitair Ziekenhuis Gent - UZ GENT — Ghent, Belgium
- Universitaire Ziekenhuizen Leuven — Leuven, Belgium
- Arthur J E Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
- Cross Cancer Institute — Edmonton, Alberta, Canada
- University Health Network UHN Princess Margaret Cancer Centre — Toronto, Ontario, Canada
- McGill University Health Centre — Montreal, Quebec, Canada
- Peking University First Hospital — Beijing, China
- West China Hospital Si Chuan University — Chengdu, China
- Sun Yat -Sen University Cancer Center — Guangzhou, China
- First affiliated Hospital of Zhejiang University — Hangzhou, China
- Shanghai Changzheng Hospital — Shanghai, China
- Shengjing Hospital Of China Medical University — Shenyang, China
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, China
- The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China
- Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez — Lille, France
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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