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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508586-33-00 | Other Identifier | EU CT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | No Intervention | A continuous therapy arm - continuation of therapy with Dara-Rd until PD | |
| Arm B | Experimental | treatment free interval arm - discontinuation of therapy with Dara-Rd, which will be resumed at biochemical progression and given until PD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daratumumab Injection | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Event-Free Survival (EFS) | To compare Event-Free Survival (EFS) from the time of randomization, between arm A continuous therapy with Dara-Rd until PD versus arm B discontinuation of therapy with Dara-Rd, resuming therapy at the first signs of biochemical progression until PD | Approximately up to 57 (EFS) months after randomization of the first patient |
| Compare Progression Free Survival (PFS) | To compare Progression Free Survival (PFS) from the time of randomization, between arm A continuous therapy with Dara-Rd until PD versus arm B discontinuation of therapy with Dara-Rd, resuming therapy at the first signs of biochemical progression until PD | Approximately up to 69 (PFS) months after randomization of the first patient |
| Measure | Description | Time Frame |
|---|---|---|
| Compare adverse event burden | To compare adverse event (AE) burden between arms | Approximately up to 69 months after randomization of the first patient |
| Compare patient-reported outcome measures (PROMs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonja Zweegman, Prof Dr MD | Contact | 0031 20 4442604 | 61467 | s.zweegman@amsterdamumc.nl |
| Maarten Seefat, MD | Contact | 0031 20 4442604 | m.seefat@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Sonja Zweegman, Prof Dr MD | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NL-Den Bosch-JBZ | Recruiting | 's-Hertogenbosch | Netherlands | |||
| NL-Almere-FLEVOZIEKENHUIS |
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| Label | URL |
|---|---|
| HOVON website | View source |
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| Dexamethasone | Drug | 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) |
|
| Lenalidomide capsule | Drug | 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) |
|
To compare PROMs between arms via validated questionnaires such as Impact of Cancer version 2 Cancer Worry scale
| Approximately up to 69 months after randomization of the first patient |
| Compare cost-effectiveness between arms | To compare cost-effectiveness between arms | Approximately up to 69 months after randomization of the first patient |
| Determine the length of the treatment-free interval | To determine the length of the treatment-free interval (TFI) in arm B | Approximately up to 69 months after randomization of the first patient |
| Determine time to (maximal) response response | To determine time to (maximal) response after restart of Dara-Rd in arm B. | Approximately up to 69 months after randomization of the first patient |
| Compare time to next treatment | To compare time to next treatment (TTNT) between arms | Approximately up to 69 months after randomization of the first patient |
| Compare time from randomization to progression on second-line therapy | To compare time from randomization to progression on second-line therapy (PFS2) between arms. | Approximately up to 69 months after randomization of the first patient |
| Compare Overall Survival | To compare Overall Survival (OS) between arms. | Approximately up to 69 months after randomization of the last patient |
| Compare the discontinuation rate | To compare the discontinuation rate and the reasons for discontinuation between arms. | Approximately up to 69 months after randomization of the first patient |
| Evaluate cumulative doses | To evaluate cumulative dose of daratumumab, lenalidomide and dexamethasone in both arms. | Approximately up to 69 months after randomization of the first patient |
| Compare dose reductions | To compare dose reductions of daratumumab, lenalidomide and dexamethasone between arms. | Approximately up to 69 months after randomization of the first patient |
| Compare toxicity | To compare toxicity according to CTCAE v5 between arms | Approximately up to 69 months after randomization of the first patient |
| Compare Quality of Life | To compare Quality of Life between arms via validated questionnaires such as QLQ-C30, MY20, EQ-5D-5L | Approximately up to 69 months after randomization of the first patient |
| Compare relative dose intensity | To compare relative dose intensity (RDI) of daratumumab, lenalidomide and dexamethasone between arms. | Approximately up to 69 months after randomization of the first patient |
| Recruiting |
| Almere Stad |
| Netherlands |
| NL-Amersfoort-MEANDERMC | Recruiting | Amersfoort | Netherlands |
| NL-Amsterdam- UMC | Recruiting | Amsterdam | Netherlands |
| NL-Amsterdam-AmsterdamUMC | Recruiting | Amsterdam | Netherlands |
| NL-Apeldoorn-GELREAPELDOORN | Recruiting | Apeldoorn | Netherlands |
| NL-Arnhem-RIJNSTATE | Recruiting | Arnhem | Netherlands |
| NL-Assen-WZA | Recruiting | Assen | Netherlands |
| NL-Beverwijk-RKZ | Recruiting | Beverwijk | Netherlands |
| NL-Delft-RDGG | Recruiting | Delft | Netherlands |
| NL-Deventer-DZ | Recruiting | Deventer | Netherlands |
| NL-Dordrecht-ASZ | Recruiting | Dordrecht | Netherlands |
| Nij Smellinghe Ziekenhuis | Recruiting | Drachten | Netherlands |
| NL-Ede-ZGV | Recruiting | Ede | Netherlands |
| NL-Emmen-SCHEPER | Recruiting | Emmen | Netherlands |
| NL-Enschede-MST | Recruiting | Enschede | Netherlands |
| NL-Goes-ADRZ | Recruiting | Goes | Netherlands |
| NL-Gorinchem-BEATRIX | Recruiting | Gorinchem | Netherlands |
| NL-Groningen-MARTINI | Recruiting | Groningen | Netherlands |
| NL-Hardenberg-SAXENBURGH | Recruiting | Hardenberg | Netherlands |
| NL-Harderwijk-STJANSDALHARDERWIJK | Recruiting | Harderwijk | Netherlands |
| NL-Helmond-ELKERLIEK | Recruiting | Helmond | Netherlands |
| NL-Hilversum-TERGOOI | Recruiting | Hilversum | Netherlands |
| NL-Hoofddorp-SPAARNEGASTHUIS | Recruiting | Hoofddorp | Netherlands |
| NL-Hoorn-DIJKLANDERHOORN | Recruiting | Hoorn | Netherlands |
| Alrijne Ziekenhuis Leiderdorp | Recruiting | Leiderdorp | Netherlands |
| HMC Antoniushove | Recruiting | Leidschendam | Netherlands |
| NL-Roosendaal-BRAVIS | Recruiting | Roosendaal | Netherlands |
| NL-Rotterdam-IKAZIA | Recruiting | Rotterdam | Netherlands |
| NL-Schiedam-FRANCISCUSVLIETLAND | Recruiting | Schiedam | Netherlands |
| NL-Sittard-Geleen-ZUYDERLAND | Recruiting | Sittard | Netherlands |
| NL-Sneek-ANTONIUSSNEEK | Recruiting | Sneek | Netherlands |
| NL-Terneuzen-ZORGSAAM | Recruiting | Terneuzen | Netherlands |
| NL-Tilburg-ETZ | Recruiting | Tilburg | Netherlands |
| NL-Uden-BERNHOVEN | Recruiting | Uden | Netherlands |
| NL-Venlo-VIECURI | Recruiting | Venlo | Netherlands |
| NL-Zaandam-ZAANSMC | Recruiting | Zaandam | Netherlands |
| NL-Zwolle-ISALA | Recruiting | Zwolle | Netherlands |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C556306 | daratumumab |
| D003907 | Dexamethasone |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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