Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase III Non-Inferiority Randomized Controlled Trial of Fixed Duration Versus Continuous Daratumumab Among Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182774
• Other study ID #: MY13
• Status: Recruiting
• Phase: Phase 3
• Start date: April 10, 2024
• Est. completion date: July 31, 2032

Study information

• Verified date: April 2024
• Source: Canadian Cancer Trials Group
• Contact: Annette Hay
• Phone: 613-533-6430
• Email: ahay[@]ctg.queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently, daratumumab, lenalidomide, and dexamethasone are given continuously (non-stop). Some recent observations suggest that stopping daratumumab after about a year and a half of treatment may work just as well as giving it continuously with lenalidomide and dexamethasone. This study is being done to answer the question: is less daratumumab treatment as good as more?

Description:

The usual approach for people with myeloma who are not having a stem cell transplant is treatment with the combination of daratumumab, lenalidomide, and dexamethasone. These drugs are given continuously until they are no longer effective or cause major side effects. Those that decide to take part in this study, will be randomly placed in one of two groups. If in the usual care group, patients will continue all the myeloma medicines currently being taken. If in the experimental group, patients will stop the daratumumab injection, and continue taking the myeloma tablets currently being taken. Regardless of which group, patients will stay on treatment indefinitely as long they are benefiting from it.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 559
• Est. completion date: July 31, 2032
• Est. primary completion date: January 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants with newly diagnosed multiple myeloma that are transplant-ineligible
• Measurable disease at the time of diagnosis, as defined by at least one of the following criteria: Serum M-protein = 5 g/L; Urine M-protein = 200 mg/24 hours; Involved serum free light chain measurement = 100 mg/L, provided serum FLC ration is abnormal; For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin = 750 mg/dL
• Received daratumumab-lenalidomide-dexamethasone for 18-20 cycles
• Obtained at least a partial response per the standard 2016 IMWG criteria
• ECOG performance status 0-3
• Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in English, French, or a provided validated language.
• Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
• Participants must be accessible for treatment and follow-up.
• In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrollment.
• Participants of childbearing potential must have agreed to use a highly effective contraceptive method.

Exclusion Criteria:

• Known history of concurrent amyloid light chain amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), and Waldenstrom's macroglobulinemia.
• Patients receiving concurrent treatment with other anti-cancer therapy that would impact the ability to comply with protocol treatment are ineligible. Note: Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of protocol treatment are eligible for this trial
• Active, uncontrolled bacterial, fungal, or viral infection within 7 days prior to enrollment.
• Known human immunodeficiency virus (HIV) with CD4 count < 350 cells/microliter. Note

that patients who are HIV positive are eligible, provided:

• They are under treatment with antiretroviral therapy for at least 4 weeks prior to enrollment, with acceptable pharmacokinetic interactions and minimal overlapping toxicity with protocol therapy AND
• HIV viral load must be < 400 copies/ml within 16 weeks prior to enrollment AND
• No history of opportunistic infections within the past year.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Daratumumab
Dose determined at enrollment
• Lenalidomide
Dose determined at enrollment
• Dexamethasone
Dose determined at enrollment

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre at Hamilton Health Sciences	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	Grand River Regional Cancer Centre	Kitchener	Ontario
Canada	Stronach Regional Health Centre at Southlake	Newmarket	Ontario
Canada	Lakeridge Health Oshawa	Oshawa	Ontario
Canada	Algoma District Cancer Program	Sault Ste. Marie	Ontario
Canada	Niagara Health System	St. Catharines	Ontario
Canada	St. Joseph's Health Centre	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Canadian Cancer Trials Group	Canadian Institutes of Health Research (CIHR), Myeloma Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival	PFS is defined as the time from date of enrollment to date of first documentation of disease progression	8.1 years
Secondary	Overall Survival	Time from enrollment to death from any cause	8.1 years
Secondary	Partial Response or Better as assessed by IMWG Criteria		8.1 years
Secondary	Incidence of Treatment-Related Grade 3-5 Adverse Events and all infections based on CTCAE 5.0		8.1 years
Secondary	Time to Next Treatment	Time from enrollment to the start of next-line treatment	8.1 years
Secondary	Post-protocol Therapy Documentation checklist	Documentation of patients 2nd line treatment after treatment completion of daratumumab, lenalidomide, and dexamethasone	8.1 years
Secondary	Quality of Life Utilizing EORTC QLQ-C30		8.1 years
Secondary	Quality of Life Utilizing FACIT-COST		8.1 years
Secondary	Health Economic Analyses Utilizing EQ-5D-5L	Value is calculated by determining the incremental costs and benefits (life years, quality adjusted life years) across the two treatment arms from two perspectives, a health system and a societal perspective	8.1 years