Relapsed multiple myeloma or refractory multiple myeloma Cancer
Conditions
Interventions
Current interventions as of 08/09/2015:
Patients will be randomised to receive treatment with either Pd (pomalidomide and dexamethasone) or CPD (pomalidomide, cyclophosphamide and dexamethasone). All
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 08/09/2015: 1. Diagnosed with symptomatic multiple myeloma and have measurable disease 2. Participants must require therapy for relapsed or refractory disease 3. Participants must have received = 2 treatment lines of anti-myeloma therapy 4. Participants must have received prior treatment with both lenalidomide and proteasome inhibitor, either as single agents or in combination regimens 5. All participants must have failed treatment with either lenalidomide or proteasome inhibitor in one of the following three ways: 5.1. Documented progressive disease on or within 60 days of completing treatment with lenalidomide and/or proteasome inhibitor 5.2. In case of prior response [= partial response (PR)] to lenalidomide or proteasome inhibitor, participants must have relapsed within 6 months after stopping treatment with lenalidomide and/or proteasome inhibitor-containing regimens 5.3. Participants who have not had a = minimal response (MR) despite receiving at least 4 cycles of treatment or who have developed intolerance/toxicity after a minimum of two cycles of lenalidomide- and/or proteasome inhibitor-containing regimen 6. Participants must have received adequate prior alkylator therapy in one of the following three ways: 6.1. As part of a stem cell transplant 6.2. A minimum of 4 consecutive cycles of an alkylator based therapy 6.3. Progression on treatment with an alkylator; provided that the participant received at least two cycles of an alkylator-containing therapy. 7. Life expectancy of at least 3 months 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 9. Required laboratory values: within 14 days of day 1 of treatment 9.1. Absolute neutrophil count (ANC) = 1.0 x 109/L (growth factor support is permitted) 9.2. Platelet count = 30 x 109/L (platelet transfusion is permitted 9.3. Creatinine Clearance > 30 mL/min 9.4. Corrected serum calcium =3.5 mmol/L 9.5. Haemoglobin = 8 g/dL (blood transfusion support is permitted) 9.6. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN) 9.7. Serum total bilirubin < 17µmol/l 10. Participants must consent to provide a bone marrow sample 11. Able to give informed consent and willing to follow trial protocol 12. Aged 18 years or over 13. Females of childbearing potential (FCBP) must agree to utilise one reliable form of contraception for 28 days prior to starting trial treatment, during the trial and for 28 days after trial treatment discontinuation and even in case of dose interruption, and must agree to regular pregnancy testing during this timeframe. 14. Females must agree to abstain from breastfeeding during trial participation and 28 days after trial drug discontinuation 15. Males must agree to use a latex condom during any sexual contact with FCBP during the trial, including during dose interruptions and for 28 days following discontinuation from this trial even if he has undergone a successful vasectomy 16. Males must also agree to refrain from donating semen or sperm while on pomalidomide including during any dose interruptions and for 28 days after discontinuation from this trial 17. All participants must agree to refrain from donating blood while on trial Previous inclusion criteria: 1. Diagnosed with symptomatic multiple myeloma and have measurable disease 2. Participants must require therapy for relapsed or refractory disease 3. Participants must have received = 2 treatment
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 08/09/2015: 1. Unable or unwilling to give a bone marrow sample for laboratory analysis. 2. Previous therapy with pomalidomide 3. Hypersensitivity to thalidomide, lenalidomide, cyclophosphamide or dexamethasone 4. Participants with non-secretory multiple myeloma 5. Peripheral neuropathy = Grade 3 6. Participants who have received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant 7. Participants who are planning for a stem cell transplant 8. Previous anti-tumour therapies including investigational medicinal products at any dose within 28 days before the start of treatment (or 5 half-lives whichever is longer). Bisphosphonates for bone disease and radiotherapy for palliative intent are permitted 9. Chronic use of steroids or any other immunosuppressive therapy 10. Participants with any one of the following: 10.1. Uncontrolled congestive heart failure 10.2. Myocardial infarction within 12 months prior to starting trial treatment 10.3. Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris. 11. Participants with gastrointestinal disease that may significantly alter absorption of pomalidomide 12. Participants unable or unwilling to undergo antithrombotic prophylactic treatment 13. Pregnant or breastfeeding females 14. Participants known to be seropositive for Human Immunodeficiency Virus (HIV) or active infectious hepatitis A, B or C 15. Any conditions including the presence of laboratory abnormalities, which places the participant at unacceptable risk if they were to participate in the trial. 16. Participants with a history of other malignancies within 5 years before the date of study entry Previous exclusion criteria: 1. Unable or unwilling to give a bone marrow sample for laboratory analysis. 2. Previous therapy with pomalidomide 3. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone 4. Participants with non-secretory multiple myeloma 5. Peripheral neuropathy = Grade 3 6. Participants who have received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant 7. Participants who are planning for a stem cell transplant 8. Previous anti-tumour therapies including investigational medicinal products at any dose within 28 days before the start of treatment (or 5 half-lives whichever is longer). Bisphosphonates for bone disease and radiotherapy for palliative intent are permitted 9. Chronic use of steroids or any other immunosuppressive therapy 10. Participants with any one of the following: 10.1. Uncontrolled congestive heart failure 10.2. Myocardial infarction within 12 months prior to starting trial treatment 10.3. Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris. 11. Participants with gastrointestinal disease that may significantly alter absorption of pomalidomide 12. Participants unable or unwilling to undergo antithrombotic prophylactic treatment 13. Pregnant or breastfeeding females 14. Participants known to be seropositive for Human Immunodeficiency Virus (HIV) or active infectious hepatitis A, B or C 15. Any conditions including the presence of laboratory abnormalities, which places the participant at unacceptable risk if they were to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 08/09/2015: Progression free survival, from randomisation until disease progression Previous primary outcome measures: Safety and toxicity, as assessed by adverse reactions throughout the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 08/09/2015: 1. Response to treatment defined as achieving at least a partial response during treatment. Maximal response will be defined as the proportion of participants achieving a response as their maximum response to treatment. Time to response will be measured from randomisation to the maximal response achieved. Duration of response will be from the time of achieving at least a partial response until disease progression. 2. Safety and toxicity, as assessed by adverse reaction throughout the trial. Previous secondary outcome measures: 1. Response to treatment defined as achieving at least a partial response during treatment. Maximal response will be defined as the proportion of participants achieving a response as their maximum response to treatment. Time to response will be measured from registration to the maximal response achieved. Duration of response will be from the time of achieving at least a partial response until disease progression. 2. Progression-free survival will be calculated from registration until disease progression or death. Overall survival will be calculated from registration to death. | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed