An Open label Study of Teclistamab in Subjects with Relapsed and Refractory Multiple Myeloma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen - Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Trial duration

5 Oct 2017 → ongoing

Decision date (initial)

2024-08-01

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-503438-40-00

EudraCT number

2016-002122-36

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Others, Pharmacokinetic, Pharmacodynamic

Part 1 (dose escalation): To identify the proposed RP2D(s) and schedule assessed to be safe for teclistamab
Part 2 (dose expansion): To characterize the safety and tolerability of teclistamab at the proposed RP2D(s)
Part 3 (Phase 2): To evaluate the efficacy of teclistamab at the RP2D

Conditions and MedDRA coding

Relapsed/Refractory Multiple Myeloma

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparecy. 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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria
2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
3. Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment
4. A female participant of childbearing potential must have a negative pregnancy test at screening
5. Willing and able to adhere to the prohibitions and restrictions specified in this protocol
6. Cohorts 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 11

1. Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
2. 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)
3. Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3
4. 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
5. Toxicities from previous anticancer therapies that have not resolved to baseline or to ≤ grade 1 (except for alopecia or peripheral neuropathy)
6. 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)
7. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM)
8. 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
9. Prior allogenic stem cell transplant ≤ 6 months
10. Prior autologous stem cell transplant ≤ 12 weeks
11. Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Part 1 (Dose Escalation): Frequency and type of DLT; Part 2 (Dose Expansion): Occurrence and severity of adverse events, serious adverse events, and laboratory values; Part 3 (Phase 2): ORR (PR or better) as defined by the IMWG criteria

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

Sponsor organisation

Janssen - Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Third parties 14

Locations

7 EU/EEA countries · 22 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 70 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications