Phase
Condition
Lymphoproliferative Disorders
Multiple Myeloma
Bone Neoplasm
Treatment
Isatuximab
Lenalidomide
Dexamethasone
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thefollowing criteria: Serum monoclonal protein (M-protein) ≥ 5 g/L; Urine M-protein ≥ 200 mg/24 hours; Involved serum free light chain measurement ≥ 100 mg/L, providedserum FLC ration is abnormal; For IgA patients whose disease can only be reliablymeasured by serum quantitative immunoglobulin ≥ 750 mg/dL
Completed 18-20 cycles of daratumumab-lenalidomide-dexamethasone orisatuximab-lenalidomide-dexamethasone.
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 qualityof life and/or health utility questionnaires in English, French, or a providedvalidated language.
Participant consent must be appropriately obtained in accordance with applicablelocal 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 daysof participant enrollment.
Participants of childbearing potential must have agreed to use a highly effectivecontraceptive method.
Exclusion
Exclusion Criteria:
Known history of concurrent amyloid light chain amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skinchanges), and Waldenstrom's macroglobulinemia.
Patients receiving concurrent treatment with other anti-cancer therapy that wouldimpact the ability to comply with protocol treatment are ineligible. Note:Participants with a prior or concurrent malignancy whose natural history ortreatment does not have the potential to interfere with the safety or efficacyassessment of protocol treatment are eligible for this trial
Active, uncontrolled bacterial, fungal, or viral infection within 7 days prior toenrollment.
Known human immunodeficiency virus (HIV) with CD4 count < 350 cells/microliter. Notethat patients who are HIV positive are eligible, provided:
They are under treatment with antiretroviral therapy for at least 4 weeks priorto enrollment, with acceptable pharmacokinetic interactions and minimaloverlapping 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.
Study Design
Study Description
Connect with a study center
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaActive - Recruiting
BCCA - Kelowna
Kelowna, British Columbia V1Y 5L3
CanadaActive - Recruiting
BCCA - Vancouver
Vancouver, British Columbia V5Z 4E6
CanadaActive - Recruiting
BCCA - Kelowna
Kelowna 5990579, British Columbia 5909050 V1Y 5L3
CanadaSite Not Available
BCCA - Vancouver
Vancouver 6173331, British Columbia 5909050 V5Z 4E6
CanadaSite Not Available
CancerCare Manitoba
Winnipeg, Manitoba R3E 0V9
CanadaActive - Recruiting
CancerCare Manitoba
Winnipeg 6183235, Manitoba 6065171 R3E 0V9
CanadaSite Not Available
The Moncton Hospital
Moncton, New Brunswick E1C 6Z8
CanadaActive - Recruiting
Regional Health Authority B, Zone 2
Saint John, New Brunswick E2L 4L2
CanadaActive - Recruiting
The Moncton Hospital
Moncton 6076211, New Brunswick 6087430 E1C 6Z8
CanadaSite Not Available
Regional Health Authority B, Zone 2
Saint John 6138517, New Brunswick 6087430 E2L 4L2
CanadaSite Not Available
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador A1B 3V6
CanadaActive - Recruiting
Dr. H. Bliss Murphy Cancer Centre
St. John's 6324733, Newfoundland and Labrador 6354959 A1B 3V6
CanadaSite Not Available
Royal Victoria Regional Health Centre
Barrie, Ontario L4M 6M2
CanadaActive - Recruiting
William Osler Health System
Brampton, Ontario L6R 3J7
CanadaActive - Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario L8V 5C2
CanadaActive - Recruiting
Kingston Health Sciences Centre
Kingston, Ontario K7L 2V7
CanadaActive - Recruiting
Grand River Regional Cancer Centre
Kitchener, Ontario N2G 1G3
CanadaActive - Recruiting
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario N2G 1G3
CanadaActive - Recruiting
London Health Sciences Centre Research Inc.
London, Ontario N6A 5W9
CanadaActive - Recruiting
Verspeeten Family Cancer Centre
London, Ontario N6A 5W9
CanadaActive - Recruiting
Stronach Regional Health Centre at Southlake
Newmarket, Ontario L3Y 2P9
CanadaActive - Recruiting
Lakeridge Health Oshawa
Oshawa, Ontario L1G 2B9
CanadaActive - Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
Algoma District Cancer Program
Sault Ste. Marie, Ontario P6B 0A8
CanadaActive - Recruiting
Niagara Health System
St. Catharines, Ontario L2S 0A9
CanadaActive - Recruiting
St. Joseph's Health Centre
Toronto, Ontario M6R 1B5
CanadaActive - Recruiting
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaActive - Recruiting
Windsor Regional Cancer Centre
Windsor, Ontario N8W 2X3
CanadaActive - Recruiting
Royal Victoria Regional Health Centre
Barrie 5894171, Ontario 6093943 L4M 6M2
CanadaSite Not Available
William Osler Health System
Brampton 5907364, Ontario 6093943 L6R 3J7
CanadaSite Not Available
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton 5969782, Ontario 6093943 L8V 5C2
CanadaSite Not Available
Kingston Health Sciences Centre
Kingston 5992500, Ontario 6093943 K7L 2V7
CanadaSite Not Available
Waterloo Regional Health Network (WRHN)
Kitchener 5992996, Ontario 6093943 N2G 1G3
CanadaSite Not Available
London Health Sciences Centre Research Inc.
London 6058560, Ontario 6093943 N6A 5W9
CanadaSite Not Available
Stronach Regional Health Centre at Southlake
Newmarket 6087701, Ontario 6093943 L3Y 2P9
CanadaSite Not Available
Lakeridge Health Oshawa
Oshawa 6094578, Ontario 6093943 L1G 2B9
CanadaSite Not Available
Ottawa Hospital Research Institute
Ottawa 6094817, Ontario 6093943 K1H 8L6
CanadaSite Not Available
Algoma District Cancer Program
Sault Ste. Marie 6141439, Ontario 6093943 P6B 0A8
CanadaSite Not Available
Niagara Health System
St. Catharines 6155721, Ontario 6093943 L2S 0A9
CanadaSite Not Available
St. Joseph's Health Centre
Toronto 6167865, Ontario 6093943 M6R 1B5
CanadaActive - Recruiting
St. Michael's Hospital
Toronto 6167865, Ontario 6093943 M5B 1W8
CanadaSite Not Available
Windsor Regional Cancer Centre
Windsor 6182962, Ontario 6093943 N8W 2X3
CanadaSite Not Available
CIUSSS de l'Est-de-I'lle-de-Montreal
Montreal, Quebec H1T 2M4
CanadaActive - Recruiting
St. Mary's Hospital
Montreal, Quebec H3T 1M5
CanadaSite Not Available
The Jewish General Hospital
Montreal, Quebec H3T 1E2
CanadaActive - Recruiting
The Research Institute of the McGill University
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
Quebec City, Quebec G1J 1Z4
CanadaSite Not Available
CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
Québec, Quebec G1J 1Z4
CanadaActive - Recruiting
CIUSSS de l'Est-de-I'lle-de-Montreal
Montreal 6077243, Quebec 6115047 H1T 2M4
CanadaActive - Recruiting
The Jewish General Hospital
Montreal 6077243, Quebec 6115047 H3T 1E2
CanadaSite Not Available
The Research Institute of the McGill University
Montreal 6077243, Quebec 6115047 H4A 3J1
CanadaActive - Recruiting
CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
Québec 6325494, Quebec 6115047 G1J 1Z4
CanadaSite Not Available
Allan Blair Cancer Centre
Regina, Saskatchewan S4T 7T1
CanadaActive - Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan S7N 4H4
CanadaActive - Recruiting
Allan Blair Cancer Centre
Regina 6119109, Saskatchewan 6141242 S4T 7T1
CanadaSite Not Available
Saskatoon Cancer Centre
Saskatoon 6141256, Saskatchewan 6141242 S7N 4H4
CanadaSite Not Available

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