Carfilzomib in combination with doxorubicin and dexamethasone (CAD) therapy in transplant eligible relapsed myeloma patients

Completed

Conditions: Multiple myeloma
Cancer

Registration Number: ISRCTN81151751

Lead Sponsor: niversity of Leeds (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 48

Inclusion Criteria

1. Able to give informed consent and willing to follow study protocol
2. Aged over 18 years, either sex
3. Patients with relapsed myeloma requiring therapy
4. Transplant eligible
5. Adequate renal function (creatinine clearance greater than or equal to 30 ml/min) within 14 days prior to study entry
6. Adequate liver function (alanine aminotransferase [ALT]/aspartate aminotransferase [AST] less than 3 x upper limit of normal [ULN]) within 14 days prior to study entry
7. Adequate bone marrow reserve (haemoglobin [Hb] greater than 8.0 g/dL, absolute neutrophil count [ANC] greater than 1.0 x 10^9/L, platelets [Plts] greater than 75 x 10^9/L) within 14 days prior to study entry
8. Female subjects of child-bearing potential must have a negative pregnancy test within 24 hours prior to starting therapy and agree to use dual methods of contraception for the duration of the study. Male subjects must agree to use a barrier method of contraception for the duration of the study if sexually active with a female of child-bearing potential.

Exclusion Criteria

1. Unable to tolerate an aggressive fluid hydration regimen (e.g. due to pre-existing pulmonary, cardiac or renal impairment)
2. Received an investigational medicinal product at any dose within 28 days of study entry (registration)
3. Concurrent or previous malignancies (less than 12 months post end of treatment) at other sites, with the exception of appropriately treated localised epithelial skin or cervical cancer. Patients with histories (greater than or equal to 12 months) of other tumours may be entered.
4. Seropositive for human immunodeficiency [HIV], or active hepatitis A, B or C infection
5. Any history of hypersensitivity to any of the study medications or excipients
6. Patients with active uncontrolled infections
7. Patients with peripheral neuropathy Common Toxicity Criteria (CTC) grade 3 or higher within 14 days prior to study entry
8. Poorly controlled or serious medical or psychiatric illness that, in the Investigator's opinion, is likely to interfere with participation and/or compliance in this clinical study
9. Pregnant or breast feeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoints for the dose escalation phase is dose limiting toxicities within the first cycle of treatment (28 days). In the dose expansion phase, the primary endpoint will be the proportion of patients achieving at least a partial response after four cycles of CAD.

Secondary Outcome Measures

Name	Time	Method
1. The proportion of patients for whom stem cell cell mobilisation is possible following CAD therapy<br>2. Safety and toxicity<br>3. Maximum response rate within four cycles of CAD<br>4. Maximum response rate within four cycles of CAD, consolidation therapy and maintenance therapy (i.e. maximum response to therapy)<br>5. Time to maximum response to therapy (i.e. within four cycles of CAD, consolidation therapy and maintenance therapy)<br>6. Progression-free survival <br>7. Feasibility of CD-maintenance therapy