Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Trial acronym
MonumenTAL-6
Clinical summary
Summary
Eligible participants will be randomly allocated to one of three treatment arms.
In Arm A (Experimental), participants will receive Talquetamab immuntherapy + Pomalidomide targeted therapy (Tal-P). Talquetamab will be given as an injection under the skin (subcutaneous or SC injection) and pomalidomide will be self-adminsitered as a single dose oral tablet. The steroid dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
In Arm B (Experimental), participants will receive Talquetamab + Teclistamab immunotherapy (Tal-Tec). Teclistamab in combination with talquetamab will both be given as an SC injection. The steroid dexamethasone may be given orally or intravenously as a pretreatment medicaition and study drug.
In Arm C (Active Comparator), participants will receive either Elotuzumab immunotherapy administered as an intravenous (IV) injection in combination with Pomalidomide and Dexamethasone orally (EPd); or Pomalidomide orally in combination with Bortezomib targeted therapy as a SC injection and Dexamethasone orally (PVd), as per investigator choice. Dexamethasone will be administered as a pretreatment medication.
Conditions
This trial is treating people with relapsed or refractory multiple myeloma who have received 1 to 4 prior lines of treatment including an anti-CD38 antibody and lenalidomide
Eligibility
Inclusion
- 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
Exclusion
- 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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
- NCT06208150 *
- 64407564MMY3009; 64407564MMY3009; 2022-502446-27-00
Trial sponsor
Janssen Research & Development, LLC
Scientific 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
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