Trial Search Results

A Study of Teclistamab, in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Janssen Research & Development, LLC

Stanford Investigator(s):

Intervention(s):

  • Drug: Teclistamab

Phase:

Phase 2

Eligibility


Inclusion Criteria: -

   - Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria

   - Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

   - Measurable disease: Multiple myeloma must be measurable by central laboratory
   assessment

   - Women of childbearing potential must have a negative pregnancy test at screening

   - Willing and able to adhere to the prohibitions and restrictions specified in this
   protocol

   - Cohort A: received at least 3 prior MM treatment lines of therapy. Prior therapy must
   include an IMiD, PI, and anti-CD38 monoclonal antibody; Cohort C: received >= 3 prior
   lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an
   anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug
   conjugate (ADC)

Exclusion Criteria:

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Iglesias
650-723-4247
Recruiting