ANZCTR - Registration (2024)

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record athttps://clinicaltrials.gov/study/NCT06208150

Registration number

NCT06208150

Ethics application status

Date submitted

5/01/2024

Date registered

17/01/2024

Date last updated

20/06/2024

Titles & IDs

Public title

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

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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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Secondary ID [1]00

64407564MMY3009

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Secondary ID [2]00

64407564MMY3009

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Universal Trial Number (UTN)

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Trial acronym

MonumenTAL-6

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Linked study record

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Health condition

Health condition(s) or problem(s) studied:

Relapsed or Refractory Multiple Myeloma00

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Condition category

Condition code

Cancer0000

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Other cancer types

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Intervention/exposure

Study type

Interventional

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Description of intervention(s) / exposure

Treatment: Drugs - Talquetamab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Teclistamab
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Bortezomib

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.

Treatment: Drugs: Talquetamab
Talquetamab will be administered as a SC injection.

Treatment: Drugs: Pomalidomide
Pomalidomide will be administered orally.

Treatment: Drugs: Teclistamab
Teclistamab will be administered as a SC injection.

Treatment: Drugs: Elotuzumab
Elotuzumab will be administered intravenously.

Treatment: Drugs: Dexamethasone
Dexamethasone will be administered either orally or intravenously.

Treatment: Drugs: Bortezomib
Bortezomib will be administered as a SC injection.

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Intervention code [1]00

Treatment: Drugs

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Comparator / control treatment

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Control group

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Outcomes

Primary outcome [1]00

Progression Free Survival (PFS)

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Timepoint [1]00

Up to 6 years 5 months

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Secondary outcome [1]00

Overall Response Rate (ORR)

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Timepoint [1]00

Up to 6 years 5 months

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Secondary outcome [2]00

Complete Response (CR) or Better Rate

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Timepoint [2]00

Up to 6 years 5 months

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Secondary outcome [3]00

Very Good Partial Response (VGPR) or Better Rate

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Timepoint [3]00

Up to 6 years 5 months

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Secondary outcome [4]00

Minimal Residual Disease (MRD)-negative CR Rate

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Timepoint [4]00

Up to 6 years 5 months

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Secondary outcome [5]00

Overall Survival (OS)

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Timepoint [5]00

Up to 6 years 5 months

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Secondary outcome [6]00

Progression Free Survival on Next-line Therapy (PFS2)

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Timepoint [6]00

Up to 6 years 5 months

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Secondary outcome [7]00

Time to Next Treatment (TTNT)

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Timepoint [7]00

Up to 6 years 5 months

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Secondary outcome [8]00

Serum Concentration of Talquetamab and Teclistamab

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Timepoint [8]00

Up to 6 years 5 months

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Secondary outcome [9]00

Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab

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Timepoint [9]00

Up to 6 years 5 months

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Secondary outcome [10]00

Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)

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Timepoint [10]00

Up to 6 years 5 months

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Secondary outcome [11]00

Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30

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Timepoint [11]00

Up to 6 years 5 months

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Secondary outcome [12]00

Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)

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Timepoint [12]00

Up to 6 years 5 months

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Secondary outcome [13]00

Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S)

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Timepoint [13]00

Up to 6 years 5 months

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Secondary outcome [14]00

Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey

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Timepoint [14]00

Up to 6 years 5 months

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Secondary outcome [15]00

Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q

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Timepoint [15]00

Up to 6 years 5 months

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Secondary outcome [16]00

Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30

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Timepoint [16]00

Up to 6 years 5 months

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Secondary outcome [17]00

Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L

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Timepoint [17]00

Up to 6 years 5 months

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Secondary outcome [18]00

Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S

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Timepoint [18]00

Up to 6 years 5 months

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Secondary outcome [19]00

Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey

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Timepoint [19]00

Up to 6 years 5 months

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Secondary outcome [20]00

Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30

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Timepoint [20]00

Up to 6 years 5 months

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Eligibility

Key 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

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Minimum age

18Years

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Maximum age

No limit

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Sex

Both males and females

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Can healthy volunteers participate?

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Key exclusion criteria

* 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

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Study design

Purpose of the study

Treatment

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Allocation to intervention

Randomised controlled trial

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Procedure for enrolling a subject and allocating the treatment (allocation concealmentprocedures)

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Methods used to generate the sequence in which subjects will be randomised (sequencegeneration)

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Masking / blinding

Open (masking not used)

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Who is / are masked / blinded?

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Intervention assignment

Parallel

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Other design features

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Phase

Phase 3

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Type of endpoint/s

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Statistical methods / analysis

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Recruitment

Recruitment status

Recruiting

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Data analysis

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Reason for early stopping/withdrawal

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Other reasons

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Date of first participant enrolment

Anticipated

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Actual

22/01/2024

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Date of last participant enrolment

Anticipated

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Actual

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Date of last data collection

Anticipated

30/06/2030

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Actual

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Sample size

Target

795

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Accrual to date

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Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

For IPD and results data, please seehttps://clinicaltrials.gov/study/NCT06208150

FAQs

Do observational studies need to be registered? ›

Both Observational and Expanded Access Studies may be registered in ClinicalTrials. gov's PRS; however, neither are considered Applicable Clinical Trials requiring registration.

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What is the purpose of a clinical trial registry? ›

The trial registration is primarily the publication of information about the design, conduct and administration of clinical trials. Posting of extended details such as summary results and publication may also be necessary.

What are registrational clinical trials? ›

For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials.

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What is Australia's local registry for clinical trials? ›

The ANZCTR includes all clinical trials with a recruitment site in Australia that are registered on ANZCTR as well as ClinicalTrials.gov, the US clinical trials registry. First, select a broad health condition.

Do observational studies need IRB approval? ›

IRB review and approval is required for projects that: Meet the definition of research. Involve human subjects and. Include any interaction or intervention with human subjects or involve access to identifiable private information.

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Do you need a 1572 for an observational study? ›

Any study operating under an IND requires submission of FDA Form 1572 to the sponser. However, it is NOT required for post-marketing and observational studies.

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Is registration of clinical trials really needed? ›

Why is trial registration Important? The registration of all interventional trials is considered to be a scientific, ethical and moral responsibility because: There is a need to ensure that decisions about health care are informed by all of the available evidence.

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What is the difference between a clinical registry and a trial? ›

In this way, registries provide what is called 'real-world data/evidence' or RWD/E. Clinical Trials– The primary difference between a trial and a registry is the 'intervention'. A trial focuses on an intervention and prospectively collects data.

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What is the difference between a study and a registry? ›

The purpose of a registry is to provide information or describe events and patterns, and often to generate hypotheses about a specific patient population to whom study results are meant to apply. Studies can be conducted of people who share common characteristics, with or without the inclusion of comparison groups.

Do clinical trials require FDA approval? ›

Learn more about Clinical Trials. Drug developers, or sponsors, must submit an Investigational New Drug (IND) application to FDA before beginning clinical research. In the IND application, developers must include: Animal study data and toxicity (side effects that cause great harm) data.

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What is the difference between a clinical study and a clinical trial? ›

Definition: Clinical trials are interventional studies and involve investigational medicinal products, whereas clinical studies can include both interventional and non-interventional studies but do not involve investigational medicinal products.

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How many clinical trials registries are there in the world? ›

The network consists of (i) Primary Registries (PRs), (ii) Data providers, and (iii) Partner registries [23]. There are currently 17 PRs. The Data providers include the PRs and ClinicalTrials.gov (CTG), of the United States (US).

Who approves clinical trials in the US? ›

IRB review

Most, but not all, clinical trials in the United States are approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal when compared with potential benefits.

Do you get paid to participate in clinical trials? ›

Most studies offer compensation to offset potential burdens that volunteers experience, like having to take time from work, pay for transportation, or hire childcare during appointments. Financial compensation is used to remove barriers to participate, rather than to encourage patients to volunteer in the first place.

Do you need ethical approval for observational studies? ›

If your study involves one of the following, formal ethics review will be needed: Direct or indirect participation of human volunteers: For example, via online questionnaires, interviews or focus groups, experimental interventions, or observational studies.

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Do you need consent for observational studies? ›

The vast majority of prospective observational studies with human participants will require an informed consent, and all should receive a formal IRB exemption before you proceed with an observational study that does not require consent.

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Are regulatory approvals mandatory for all observational studies? ›

There is no uniformity regarding the requirement of approval from the Ethical Committee for an observational study design among scientific journals. A few journals require it even for case reports, or case series, while others do not require it even for prospective observational studies.

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What makes an observational study valid? ›

Evaluating the Validity of an Observational Study

Whereas precision is a lack of random error, validity refers to a lack of systematic error. Observational studies are evaluated in terms of both internal and external validity. Internal validity refers to the strength of the inferences from the study.