Multiple Myeloma
Conditions
Keywords
Allogeneic stem cell transplantation, Lenalidomide, IMiD
Brief summary
Subjects up to the age of 65 years with newly diagnosed multiple myeloma requiring treatment are eligible. Minimal pretreatment (2 cycles of chemotherapy; local irradiation; surgery) is permitted. After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone. If at least a minimal response is achieved to RAD, they will undergo chemomobilization (cyclophosphamide, etoposide) of peripheral blood stem cells and one uniform cycle of high-dose melphalan chemotherapy followed by a first stem cell transplant. If any of the high-risk features (such as elevated beta 2-microglobulin, adverse cytogenetic factors, elevated LDH, Ig A isotype) were present at diagnosis, patients will be allocated to a consolidative allogeneic transplant following dose-reduced conditioning. If no appropriate donor is available, the patient does not consent or lacks of high-risk features a second autograft following high-dose melphalan will be delivered. All patients will proceed to lenalidomide maintenance (one year) following hematopoietic reconstitution.
Interventions
PROCEDUREallogeneic stem cell transplant versus second autologous transplantation
Transplantation of stem cells from a MRD or MUD, respectively after dose-reduced conditioning versus autologous stem cell graft after preparation with melphalan 200 mg/m²
DRUGRAD
After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone.
Sponsors
ClinAssess GmbH
Celgene Corporation
Amgen
medac GmbH
Wuerzburg University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Newly diagnosed multiple myeloma * Maximum of one prior systemic therapy (2 cycles) * Presence of CRAB criteria * Measurable disease parameters * Left ventricular ejection fraction at least 55% * DLCO of at least 60% * Adequate bone marrow function * Use of adequate contraception for female subjects with childbearing potential and all male subjects * Eligible for autologous and allogeneic stem cell transplantation * Bone marrow baseline sample evaluable for interphase cytogenetics
Exclusion criteria
* Any serious medical conditions preventing the subject from written informed consent * Progressive disease (PD) to any initial treatment * Pregnant or lactating females * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data * Use of any other experimental drug or therapy within 28 days of baseline * Preexisting neuropathy of ≥ grade 2 severity * Known hypersensitivity to thalidomide * Any prior use of lenalidomide * Positive for HIV or infectious hepatitis, type A, B or C after serologic testing * Serum creatinine despite induction therapy ≥ 2.0 mg/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate to RAD induction and transplant (stringent CR, CR, very good PR) | 9 months from start of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | 9 months from start of treatment |
| Incidence and relationship of severe adverse events | 1 year from start of treatment |
Countries
Germany
Outcome results
None listed