Cycle 4 Results

 I've been waiting anxiously all week to find out how the test results came out after finishing Cycle 4 of the MLN9708 protocol.  I got some preliminary results on Saturday from the online Patient Gateway which looked very promising.  I called Kathy Colson today to get the electrophoresis report, which quantifies the M Spike, and the immunofixation report, which detects any trace monoclonal gammopathy.

I was a bit disappointed to find that the report was the same as last month, i.e., no M Spike could be "quantitated" on the electrophoresis, but immunofixation showed that there is still a faint M Spike.  This means that I must still be classified as VGPR rather than CR.  Complete Response requires that the immunofixation test be negative.  Drat!  However, I am still quite happy with the results, because almost all the numbers showed significant improvement over last month.  Here is an update to my test results going back to the start of the clinical trial:
 

Test Name	Reference Range	8/1	8/30	9/27	10/25	11/29
Gamma M Spike	0 g/dL	1.96	0.41	0.13	0	0
IgA	70-400 mg/dL	3180	659	148	80	88
IgG	700-1600 mg/dL	246	248	292	249	312
IgM	40-230 mg/dL	<5	9	15	28	24
Kappa/Lambda	0.26-1.65	578	26.7	4.5	3.4	0.7
24hr urine total protein	<102 mg/24 hr	392	60	38	47	20
Albumin	3.7-5.3 g/dL	3.5	3.8	3.7	3.8	4
Beta2-microglobulin	<2.7 mg/L	3.3	1.9	1.8	2.4	1.7
Red Blood Cell Count	4.2-5.6 M/mcL	3.4	3.7	3.9	3.8	4.1
Hemoglobin	13.2-16.7 g/dL	11	11.3	11.7	11.5	12.2

The most dramatic change is the Kappa/Lambda ratio, which is now in the normal range!   That's a 99.9% drop since August.  This means there are far fewer of those nasty free monoclonal Kappa light chains floating around in there, which has to be good news.  I was also pleased to note that the urine protein levels continue to drop, and both albumin and beta-2 microglobulin are going in the right direction.  My anemia numbers (RBC, Hgb) have also moderated to the best levels since I started, and I notice that I am not feeling as tired as I was.  Despite the existence of trace amounts of M protein, it is clear that I am continuing to respond well to the treatment.  (I'm taking time out here for a couple of Hurrays and Yippees and to jump up and down with my new-found energy.)

Everything I have learned so far about MM treatment indicates that one of the best prognoses for long-term survival is to achieve good response to the initial induction therapy.  For those undergoing stem cell transplant, achieving CR either before or shortly after ASCT offers the best chance for long-term remission.  At the rate I am going, I would hope to achieve CR over the next couple of cycles and continue to deepen the response to the therapy. I would be much more inclined to volunteer for the ASCT clinical trial that Richardson is recommending if I achieve CR in the meantime.  However, I won't feel like rushing into it as long as the MLN9708 continues to work its magic.  I'm not sure how to balance these considerations, but I have time to figure it out.  In the end, I suppose I will do what Dr. Richardson recommends, but we'll see.

Today, Kathy told me that Dr. Richardson has decided not to collect my stem cells until after Cycle 6 of the protocol.  That means it won't happen before late January or February.  That's fine with me.  It gives more time for the current protocol to continue to beat down the MM before collection, and it also gives me more time to decide about whether to enlist in the new ASCT clinical trial.  The only down side to waiting on stem cell collection is that Revlimid reduces the stem cell count, which can make it harder to collect sufficient stem cells if we wait too long.  But Dr. Richardson knows what he's doing, so I'm not worried about this.