NCT02315716

Carfilzomib/Cyclophosphamide/Dexamethasone with Maintenance Carfilzomib in Multiple Myeloma

Carfilzomib/Cyclophosphamide/Dexamethasone with Maintenance Carfilzomib in Untreated Transplant-eligible Patients with Symptomatic MM to Evaluate the Benefit of Upfront ASCT

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Cardamon trial is a phase 2 trial using the standard chemotherapy drugs cyclophosphamide and dexamethasone in combination with a new drug called Carfilzomib in patients with multiple myeloma.

Detailed description

Multiple Myeloma is a cancer of the bone marrow and, for those patients that are young and fit enough, the disease is usually treated with chemotherapy (sometimes called induction chemotherapy) followed by a stem cell transplant using the patient's own stem cells (autograft or Autologous Stem Cell Transplant). Unfortunately almost all patients will experience a relapse at some point following this treatment. After relapse there are a number of treatment options but eventually the disease will become resistant to further therapy. The use of an Autologous Stem Cell Transplant (or Transplant) after initial chemotherapy treatment has been shown in studies to increase the amount of time that patients are without symptoms of their myeloma before unfortunately their disease relapses. However, recently more effective induction chemotherapy regimens have been developed and patients treated with these new regimens are able to achieve higher and deeper responses than those previously treated on older regimens. Many also achieve complete or very good partial response, which was rare with the traditional chemotherapy regimens. So, the investigators now do not know if giving patients an Autologous Stem Cell Transplant straight after their initial induction chemotherapy is the best thing to do. It may be that patients who respond well to a new drug containing regimen will obtain most benefit from their stem cells if these stem cells are frozen and stored, so that they can be used when their disease relapses. In the Cardamon trial, the investigators will directly compare the outcome of patients who receive a transplant, versus those patients who do not and who instead receive Consolidation therapy. After induction treatment and stem cell harvest, patients will be randomly allocated to receive either a transplant or to receive consolidation therapy. Patients in the Cardamon trial will also be given maintenance treatment. This is treatment that is given on an ongoing basis, after the transplant or after the Consolidation therapy. The aim of maintenance treatment is to prolong disease response and delay the time to relapse. In summary the purpose of the Cardamon study is: 1. to confirm the high response rate to a new treatment regime that includes Carfilzomib plus 2 standard chemotherapy drugs used for the treatment of Multiple Myeloma, 2. to investigate whether patients who respond well to this new Carfilzomib-containing induction regimen are able to maintain a long remission period without having an Autologous Stem Cell Transplant 'up-front', and 3. to find out if maintenance treatment with Carfilzomib is able to further reduce the number of remaining myeloma cells in the bone marrow, using the Minimal Residual Disease test.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
PROCEDURE	Autologous Stem Cell Transplant (ASCT)	Randomisation to melphalan conditioned autologous stem cell transplant
DRUG	Consolidation with 4 cycles of CarCyDex	Randomisation to 4 further cycles of Carfilzomib, Cyclophosphamide and Dexamethasone for responding patients following 4 cycles of induction chemotherapy

Timeline

• Start date: 2015-06-16
• Primary completion: 2019-11-01
• Completion: 2029-11-01
• First posted: 2014-12-12
• Last updated: 2024-12-06

Locations

20 sites across 1 country: United Kingdom