A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide (MonumenTAL-6)
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- Full Title:
- A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants With Relapsed or Refractory Myeloma Who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide
- Myeloma stage or condition:
- Relapsed or Refractory Multiple Myeloma
- Study phase:
- Phase 3
- Summary/Purpose:
- The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
- Detailed Description:
- Not available
- Treatments:
- Drug : Talquetamab
Talquetamab will be administered as a SC injection.
- Drug : Pomalidomide
Pomalidomide will be administered orally.
- Drug : Teclistamab
Teclistamab will be administered as a SC injection.
- Drug : Elotuzumab
Elotuzumab will be administered intravenously.
- Drug : Dexamethasone
Dexamethasone will be administered either orally or intravenously.
- Drug : Bortezomib
Bortezomib will be administered as a SC injection.
- Study Arms:
- Experimental : Arm A: Talquetamab + Pomalidomide (Tal-P)
Participants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. - Experimental : Arm B: Talquetamab + Teclistamab (Tal-Tec)
Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. - Active Comparator : Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd)
Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication.
- Study Type:
- Interventional
- Study Design:
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Recruitment status:
- Recruiting
- Eligibility criteria:
-
Inclusion Criteria:
- Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level >= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
- Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator's determination of response by IMWG criteria on or after their last regimen
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
- A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6months after the last dose of study treatment
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
- Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
- Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
- A maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Locations / Centres:
-
Juravinski Cancer Centre, Hamilton, Ontario – Recruiting
University Health Network (UHN) Princess Margaret Cancer Centre, Toronto, Ontario – Recruiting
CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont, Montreal, Quebec – Recruiting
- Contacts:
- Name: Study Contact
Phone: 844-434-4210
Email: [email protected]
- Publications:
- ???
- First posted:
- 2024-01-17
- Actual start date:
- January 22, 2024
- Last updated:
- 2024-04-23
- Estimated enrollment:
- 795
- Estimated completion date:
- 2030-06-30
- Estimated primary completion date:
- 2026-04-23
- Condition:
- Relapsed or Refractory Multiple Myeloma
- Gender:
- All
- Ages:
- 18 Years-N/A
- Accepts healthy volunteers:
- No
- Listed location countries:
- Australia
- Belgium
- Canada
- China
- Czechia
- Denmark
- France
- Germany
- India
- Israel
- Italy
- Japan
- Korea, Republic of
- Netherlands
- Poland
- Spain
- Sweden
- United Kingdom
- NCT number:
- NCT06208150
- Other study ID numbers:
- 64407564MMY3009
- Has Data monitoring committee:
- Yes
- U.S. FDA-regulated product:
- Yes
- IPD Sharing Statement :
- ???
- Responsible party:
-
Sponsor
- Study sponsor:
- lead_sponsor
Janssen Research & Development, LLC
Industry
- Collaborators:
- ???
- Investigators:
- Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
- Protocol Registration and Results System:
- ???
- Verification date:
- 2024-04-01