The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06182774
Recruitment Status : Recruiting
First Posted : December 27, 2023
Last Update Posted : April 12, 2024
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Myeloma Canada
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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?

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Daratumumab Drug: Lenalidomide Drug: Dexamethasone Phase 3

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 559 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 10, 2024
Estimated Primary Completion Date : January 31, 2032
Estimated Study Completion Date : July 31, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Lenalidomide & Dexamethasone Drug: Lenalidomide
Dose determined at enrollment

Drug: Dexamethasone
Dose determined at enrollment
Active Comparator: Daratumumab, Lenalidomide & Dexamethasone
Standard of Care
 Drug: Daratumumab
Dose determined at enrollment

Drug: Lenalidomide
Dose determined at enrollment

Drug: Dexamethasone
Dose determined at enrollment


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 8.1 years ]
    PFS is defined as the time from date of enrollment to date of first documentation of disease progression


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 8.1 years ]
    Time from enrollment to death from any cause

  2. Partial Response or Better as assessed by IMWG Criteria [ Time Frame: 8.1 years ]
  3. Incidence of Treatment-Related Grade 3-5 Adverse Events and all infections based on CTCAE 5.0 [ Time Frame: 8.1 years ]
  4. Time to Next Treatment [ Time Frame: 8.1 years ]
    Time from enrollment to the start of next-line treatment

  5. Post-protocol Therapy Documentation checklist [ Time Frame: 8.1 years ]
    Documentation of patients 2nd line treatment after treatment completion of daratumumab, lenalidomide, and dexamethasone

  6. Quality of Life Utilizing EORTC QLQ-C30 [ Time Frame: 8.1 years ]
  7. Quality of Life Utilizing FACIT-COST [ Time Frame: 8.1 years ]
  8. Health Economic Analyses Utilizing EQ-5D-5L [ Time Frame: 8.1 years ]
    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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06182774


Contacts
Layout table for location contacts
Contact: Annette Hay 613-533-6430 ahay@ctg.queensu.ca

Locations
Layout table for location information
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Hira Mian    905-387-9495    mianh@hhsc.ca   
Sponsors and Collaborators
Canadian Cancer Trials Group
Canadian Institutes of Health Research (CIHR)
Myeloma Canada
Investigators
Layout table for investigator information
Study Chair: Hira Mian Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario Canada
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT06182774    
Other Study ID Numbers: MY13
First Posted: December 27, 2023    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient data may be shared once the final analysis is complete following the Canadian Cancer Trials Group Data Sharing Policy available at https://ctg.queensu.ca/
URL: http://ctg.queensu.ca/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
 Lenalidomide
Daratumumab
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors