Carfilzomib/Cyclophosphamide/Dexamethasone With Maintenance Carfilzomib in Multiple Myeloma (Cardamon)
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|ClinicalTrials.gov Identifier: NCT02315716|
Recruitment Status : Active, not recruiting
First Posted : December 12, 2014
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Procedure: Autologous Stem Cell Transplant (ASCT) Drug: Consolidation with 4 cycles of CarCyDex||Phase 2|
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:
- 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,
- 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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||281 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Carfilzomib/Cyclophosphamide/Dexamethasone With Maintenance Carfilzomib in Untreated Transplant-eligible Patients With Symptomatic MM to Evaluate the Benefit of Upfront ASCT|
|Actual Study Start Date :||June 16, 2015|
|Actual Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2029|
Experimental: Consolidation with 4 cycles of CarCyDex
Patients responding to induction treatment will receive 4 further cycles of Carfilzomib, Cyclophosphamide and Dexamethasone (CarCyDex) treatment followed by 18 months of maintenance carfilzomib
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
Active Comparator: ASCT
Patients responding to induction treatment will receive a melphalan conditioned autologous stem cell transplant followed by 18 months of maintenance carfilzomib
Procedure: Autologous Stem Cell Transplant (ASCT)
Randomisation to melphalan conditioned autologous stem cell transplant
- Response rate [ Time Frame: Within 4 weeks of the end of induction treatment ]Major response rate (sCR, CR & VGPR) to 4 cycles of CarCyDex
- PFS [ Time Frame: 2 years after randomisation ]Progression free survival at 2 years for both ASCT and non-ASCT (consolidation) arms
- Toxicity [ Time Frame: From start of treatment until 30 days post end of maintenance treatment ]Adverse Events (including peripheral neuropathy), dose reductions and delays, tolerability of the induction and maintenance regimens (treatment delays, discontinuation rates)
- Disease response rate [ Time Frame: Within 4 weeks of the end of induction treatment ]Disease response rate (sCR, CR, VGPR, PR) to CarCyDex induction
- PFS [ Time Frame: Assessed every 6 months from the end of treatment until 36 months post induction ]PFS in both the ASCT and non-ASCT arms
- Overall survival [ Time Frame: Assessed every 6 months from the end of treatment until 36 months post induction ]Overall survival in both the ASCT and non-ASCT arms
- MRD conversion following treatment [ Time Frame: Baseline, Day 100 post ASCT or within 4 weeks of the end of consolidation treatment ]Improvement in disease response and conversion from MRD-positive to MRD-negative post ASCT and post Consolidation
- MRD conversion following maintenance [ Time Frame: Baseline, after 6 months of maintenance ]Improvement in disease response and conversion from MRD-positive to MRD-negative after 6 months of maintenance treatment
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): NCT02315716
|Principal Investigator:||Kwee Yong||University College, London|