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RECRUITINGPhase 3INTERVENTIONAL

FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)

FeAsiBility of a Treatment Free Interval in Newly Diagnosed mUltiple myeLOma Patients Treated With DaratumUmab-Lenalidomide-DexamethaSone- the FABULOUS Study. A Nationwide Open-label Randomized Phase III Clinical Trial Comparing Daratumumab-lenalidomide-dexamethasone Continuously Versus Including a Treatment Free Interval

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

In the Netherlands, the standard treatment for multiple myeloma is a combination of different medicines named daratumumab-lenalidomide-dexamethasone, abbreviated as Dara-Rd. In many patients this treatment results in suppressing the disease for a long time. The treatment is continued until it is not effective anymore and the disease progresses. But until now it is unknown whether continuous therapy also leads to prolonging life. In addition, there are concerns about side effects, leading to a reduced quality of life, the development of severe toxicity that remains, which hampers subsequent therapy, and high costs due to prolonged treatment. There are indications that temporarily stopping treatment is safe, leading to fewer side effects and allows recovering from toxicity or damage due to treatment. This may improve the quality of life.

Who May Be Eligible (Plain English)

Who May Qualify: - Patient was diagnosed with MM, based on the IMWG criteria, and measurable disease at the time of diagnosis (appendix A). - Age ≥ 18 years. - Patient was treated with 12 cycles (13 cycles is accepted) of Dara-Rd and will continue treatment with Dara-Rd. Reduced dosing of lenalidomide, but not to less than 5 mg, and previous discontinuation or dose reduction of dexamethasone is allowed. - Partial response or better after treatment with 12 cycles of Dara-Rd, without signs of biochemical progression. - white blood cell count (ANC) at least 1.0x109/L and platelet count at least 75x109/L. - Patient is capable of giving willing to sign a consent form. - Written willing to sign a consent form. Who Should NOT Join This Trial: - Patient with non-secretory MM at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd. - Patient in whom a plasmacytoma was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd. - Patient in whom urine M-protein was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd. - Patient in whom treatment with daratumumab, lenalidomide or both has been discontinued for whatever reason (patients may only have discontinued dexamethasone). - Patient in whom continuation of treatment with Dara-Rd is deemed not feasible because of medical reasons. - Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patient was diagnosed with MM, based on the IMWG criteria, and measurable disease at the time of diagnosis (appendix A). * Age ≥ 18 years. * Patient was treated with 12 cycles (13 cycles is accepted) of Dara-Rd and will continue treatment with Dara-Rd. Reduced dosing of lenalidomide, but not to less than 5 mg, and previous discontinuation or dose reduction of dexamethasone is allowed. * Partial response or better after treatment with 12 cycles of Dara-Rd, without signs of biochemical progression. * ANC ≥ 1.0x109/L and platelets ≥ 75x109/L. * Patient is capable of giving informed consent. * Written informed consent. Exclusion Criteria: * Patient with non-secretory MM at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd. * Patient in whom a plasmacytoma was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd. * Patient in whom urine M-protein was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd. * Patient in whom treatment with daratumumab, lenalidomide or both has been discontinued for whatever reason (patients may only have discontinued dexamethasone). * Patient in whom continuation of treatment with Dara-Rd is deemed not feasible because of medical reasons. * Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Treatments Being Tested

DRUG

Daratumumab Injection

Patients who have been treated with 12 cycles of Daratumumab-Lenalidomide-Dexamethasone (Dara-Rd) will be randomized between Arm A (continuous therapy) and Arm B (treatment free interval)

DRUG

Dexamethasone

Patients who have been treated with 12 cycles of Daratumumab-Lenalidomide-Dexamethasone (Dara-Rd) will be randomized between Arm A (continuous therapy) and Arm B (treatment free interval)

DRUG

Lenalidomide capsule

Patients who have been treated with 12 cycles of Daratumumab-Lenalidomide-Dexamethasone (Dara-Rd) will be randomized between Arm A (continuous therapy) and Arm B (treatment free interval)

Locations (20)

NL-Den Bosch-JBZ
's-Hertogenbosch, Netherlands
NL-Almere-FLEVOZIEKENHUIS
Almere Stad, Netherlands
NL-Amersfoort-MEANDERMC
Amersfoort, Netherlands
NL-Amsterdam- UMC
Amsterdam, Netherlands
NL-Amsterdam-AmsterdamUMC
Amsterdam, Netherlands
NL-Apeldoorn-GELREAPELDOORN
Apeldoorn, Netherlands
NL-Arnhem-RIJNSTATE
Arnhem, Netherlands
NL-Assen-WZA
Assen, Netherlands
NL-Beverwijk-RKZ
Beverwijk, Netherlands
NL-Delft-RDGG
Delft, Netherlands
NL-Deventer-DZ
Deventer, Netherlands
NL-Dordrecht-ASZ
Dordrecht, Netherlands
Nij Smellinghe Ziekenhuis
Drachten, Netherlands
NL-Ede-ZGV
Ede, Netherlands
NL-Emmen-SCHEPER
Emmen, Netherlands
NL-Enschede-MST
Enschede, Netherlands
NL-Goes-ADRZ
Goes, Netherlands
NL-Gorinchem-BEATRIX
Gorinchem, Netherlands
NL-Groningen-MARTINI
Groningen, Netherlands
NL-Hardenberg-SAXENBURGH
Hardenberg, Netherlands