Table I.
Morphologic and Classical Cytogenetic Findings in Three Different Groups Treated with Lenalidomide for Myeloma
| Evaluation Time Point | Newly diagnosed MM patients
|
Relapsed/refractory MM patients
|
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Pre-treatment LD+LD/ASCT groups |
LD Alone Treatment Group (14 patients)
|
LD/ASCT Treatment Group (18 patients)
|
BLD Treatment Group (8 patients)
|
||||||
| Post 6–9 LD cycles | Follow-up* (median 14 mos.; range 12–29 mos.) | Post 3–4 LD cycles | 3 months post ASCT | Follow-up* (median 18 mos.; range 12–27 mos.) | Pre-treatment | End of treatment post 4–8 BLD cycles | Follow-up* (median 15 mos.; range 13–23 mos.) | ||
| Mean marrow blast % ± 2SD | 0.5 ± 0.8 | 0.4 ± 1.0 | 0.1 ± 0.8 | 0.3 ± 0.8 | 0.3 ± 0.6 | 0.5 ± 1.5 | 0.4 ± 0.5 | 0.3 ± 0.3 | 0.3 ± 0.6 |
| Severe dysplasia, n/specimens (%) | 0/29 | 0/13 | 1/8 (12)† | 0/18 | 0/15 | 0/10 | 0/7 | 0/8 | 0/5 |
| Non-severe dysplasia, n/specimens (%) | 5/29 (17) | 6/13 (46) | 4/8 (50) | 2/18 (11) | 3/15 (20) | 0/10 (0) | 5/7 (71) | 7/8 (88) | 3/5 (60) |
| Erythroid, n | 2 | 3 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| Granulocytes, n | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Megakaryocytes, n | 3 | 4 | 3 | 2 | 3 | 0 | 5 | 7 | 3 |
| Classical cytogenetic studies, n/specimens (%) | |||||||||
| Normal karyotype | 23/27 (85) | 12/13 (92) | 6/8 (75) | 17/17 (100) | 14/15 (93) | 8/10 (80) | 6/7 (86) | 7/8 (88) | 3/4 (75) |
| Clonal changes related to MM | 3/27 (11) | 1/13 (8) | 0 | 0 | 0 | 1/10 (10) | 1/7 (14) | 1/8 (12) | 1/4 (25) |
| Clonal changes not likely related to MM | 1/127 (4)‡ | 0 | 2/8 (25)† | 0 | 1/15 (7)§ | 1/10 (10)§ | 0 | 0 | 0 |
LD, lenalidomide & dexamethasone; ASCT, autologous stem cell transplant; BLD, bendamustine, lenalidomide and dexamethasone.
One patient from LD alone had three follow-up evaluations, one patient from LD/ASCT had two follow-up evaluations and one patient from BLD had two follow-up evaluations; the median and range for follow-up are determined from the last follow-up evaluation.
Severe dyserythropoiesis and dysmegakaryopoiesis was seen in the specimen diagnostic for MDS in 1 patient from the LD alone group 13 mos. after initiation of LD alone therapy (i.e., also 3 months after initiation of Velcade/dexamethasone salvage therapy); a clonal cytogenetic abnormality was detected at this time and persisted on follow-up 18 mos. after initiation of LD alone therapy.
A clonal cytogenetic abnormality was detected in 1 patient from the LD/ASCT therapy group at 3 mos. post ASCT and on follow-up at 10 mos. post ASCT, but was not detected on a final follow-up specimen (details described under results)