On-going trials – Closed to recruitment
MUK twelve
A Phase 2 trial evaluating the safety and efficacy of selinexor in combination with cyclophosphamide and prednisolone versus cyclophosphamide and prednisolone in relapsed/refractory myeloma patients.
This trial aims to show that the addition of selinexor to cyclophosphamide and prednisolone improves progression free survival in relapsed/refractory patients.
What this means for patients
The results from this trial will increase the evidence for the use of selinexor in combination with cyclophosphamide and prednisolone in relapsed/refractory patients.
Trial delivery funded by Karyopharm
MUK seven
A randomised Phase 2 trial comparing pomalidomide (Inovid ®), cyclophosphamide and dexamethasone (CPD) to pomalidomide and dexamethasone (PD) in relapsed/refractory myeloma patients.
This trial aims to show that CPD is comparable to or better than PD. The trial will also screen patient samples to look for biomarkers (e.g. differences in genetics or immune cell composition) which correlate with lower responses to pomalidomide to help predict patient response to pomalidomide.
What this means for patients
Preliminary results from this trial showed that CPD significantly increases response rates and depth of response compared to pomalidomide and dexamethasone in relapsed/refractory patients. These results increase the evidence for CPD as a treatment for relapsed/refractory patients.
Funded by Celgene and Myeloma UK
Publication(s):
- Croft, J., Hall, A., Walker, K., Sherborne, A.L., Ellis, S., Price, A., Sherratt, D., Reed, S., Pawlyn, C., Garg, M. and Boyd, K., (2018). Cyclophosphamide, Pomalidomide and Dexamethasone Significantly Improves Response over Poma/Dex in Relapsed/Refractory Myeloma Patients Previously Treated with Cyclophosphamide Combination Therapy-Initial Results of the Randomised Multicentre Mukseven Trial. 132:(Suppl. 1), 3274
- Croft, J., Hall, A., Walker, K., Sherborne, A.L., Boyd, K., Garg, M., Pawlyn, C., Sherratt, D., Reed, S., Pierceall, W.E. and Cook, G., (2018). Cyclophosphamide Exerts Significant Immunomodulatory Function in Myeloma Patients Treated with Pomalidomide and Dexamethasone. 132:(Suppl. 1), 4482
- Sherborne, A.L., Shah, V., Hall, A., Walker, K., Ellis, S., Begum, F., Johnson, D.C., Croft, J., Kendall, J., Pawlyn, C. and Atanesyan, L., (2017). Molecular Profiling of Relapsed and Refractory Myeloma Identifies Frequent Bi-Allelic Driver Events—Interim Results of the ‘Myeloma UK Seven’Biomarker Trial. 130:(Suppl. 1), 1851.
MUK eight
A randomised Phase 2 trial comparing a combination of ixazomib (Ninlaro®) with cyclophosphamide and dexamethasone (ICD) against cyclophosphamide and dexamethasone (CD) in relapsed/refractory myeloma patients.
This trial aims to show that ICD is comparable to or better than CD, delivering improved response rates in relapsed/refractory patients.
What this means for patients
The results from this trial will increase the evidence for ICD in relapsed/refractory patients.
Funded by Takeda and Myeloma UK
MUK nine
A Phase 2 trial with two parts. This trial aims to find out if a multi-targeted combination of five drugs could improve outcomes in high-risk myeloma patients.
In the first part, MUK nine a, over 700 newly diagnosed patients will be screened using genetic analysis of their bone marrow samples. Those patients who are identified as being at high-risk will be offered the opportunity to take part in MUK nine b.
In the second part, MUK nine b, patients defined as high-risk in MUK nine a will be given a combination of bortezomib (Velcade®), lenalidomide (Revlimid®) dexamethasone, daratumumab (Darzalex®) with cyclophosphamide as induction treatment prior to high dose therapy and stem cell transplant. Patients will then receive consolidation (daratumuab, bortezomib and lenalidomide) and maintenance (daratumuab and lenalidomide) treatments.
What this means for patients
The results from this trial will give a greater understanding of how to treat high-risk myeloma patients. It will also help demonstrate how genetic screening from patient bone marrow can be used to group and treat certain myeloma patients (known as stratified medicine).
Funded by Celgene and Janssen
Publication(s):
- Shah, V., Hinsley , S., Sherborne, A., Ellis, S., Price, A. , Kendall, J., Johnson, D., Owen, R., Drayson, M., Flanagan, L., Sherratt, D., Gregory, W., Jackson, G., Pratt, G., Cook, G., Brown, S., Jenner, M., Kaiser, M. (2018) Optimising treatment for high-risk myeloma in a stratified multicentre trial: experience from the MUK nine Optimum study. 23rd Annual Meeting of the European Haematological Association. Abstract PS1334
- Sherborne, A.L., Shah, V., Ellis, S., Begum, F., Kendall, J., Johnson, D.C., Owen, R.G., Drayson, M.T., Flanagan, L., Sherratt, D. and Gregory, W.M., (2017). Improving Outcomes for Patients with High-Risk Myeloma Via Prospective Trial Evidence: The Myeloma UK Nine Optimum Trial. 130: (Suppl. 1), 1767.
MUK eleven
A Phase 1 trial to assess the safety and efficacy of Reolysin®, a reovirus, in combination with lenalidomide and pomalidomide in relapsed/refractory myeloma patients.
This trial is the first human trial assessing the efficacy and safety of Reolysin in combination with lenalidomide and pomalidomide. It aims to identify the most effective dose of Reolysin and show that it is well tolerated.
What this means for patients
These result will provide further evidence towards the use of viruses to treat myeloma. There are currently no viral treatments licenced to treat myeloma, therefore, this work could help to find a way to kill myeloma cells.
Funded by Celgene and Myeloma UK