I currently have high-risk smoldering multiple myeloma an am in Dr. Ola Landgren's study of myeloma and its precursor states at the National Institute's of Health. Dr. Landgren is a respected myeloma expert and an incredibly wonderful person as well.
As per the "CRAB" criteria, I am holding my own, except my hemoglobin (i.e. anemia) is now at about 12.0. I am a 49 year old guy. The other three factors – calcium, creatinine, and bone involvement – are normal. I am clearly near the cutoff that would trigger treatment. At the NIH, that would be 11.7 for hemoglobin.
Dr. Landgren has a trial with carfilzomib (Kyprolis), Revlimid, and dexamethasone that is the only one in the country for newly diagnosed multiple myeloma patients. I am also monitored at UPenn, where I would probably get the standard treatment.
If any one can give me any advice or insight about the carfilzomib, Revlimid, and dexamethasone trial, I would appreciate it. Obviously, I want to do my home work now so as to help in my decision making.
Thanks!
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terryl1 - Name: Terry
- Who do you know with myeloma?: self
- When were you/they diagnosed?: August 10, 2011
- Age at diagnosis: 49
Re: Carfilzomib, Revlimid & dex for newly diagnosed myeloma
I am glad to hear that you are under such good care. Regarding potential treatment options: When they become necessary, I always recommend clinical trials when and where available. It is because of clinical trials and interested patients such as yourself that we developed new agents and therapies, e.g. Velcade and/or Revlimid today.
In newly diagnosed patients, one can recommend a handful of 2 and 3 drug combinations as standard of care. Each with differing toxicities and response rates. However, we still do not know what the best choice is for our patients.
With new drugs like carfilzomib, which had excellent activity alone and even better in combination with Revlimid and dexamethasone in relapsed refractory patients, we also want to know if this may improve on responses, tolerability, and eventually progression-free survival and overall survival in newly diagnosed patients. To answer this question, we need clinical trials.
The results of a phase I/II study using this combination (CRd) in 58 patients (only 51 we were evaluable) with newly diagnosed myeloma was presented at the ASH meeting this December (Jakubowiak et al ASH 2011 #631). It demonstrated very exciting results in terms of response. Responses were rapid with 46/49 patients achieving at least PR (partial response: >50% reduction) after a single cycle. These response results improved with the duration of treatment, reaching 100% ≥PR after 4 cycles and 100% ≥VGPR (very good partial response: >90% reduction), 79% CR/nCR (complete response or near CR) after 12 cycles. PFS and OS will take some time to mature (i.e., the trial has not gone on long enough to know the answers).
Remember that response dose not directly equate to progression-free survival and overall survival, but this early in the maturation of the results I would remain optimistic. Remember there always toxicities that one has to help define as well in clinical trials.
As stated above, I do recommend clinical trials for anyone with myeloma, whether newly diagnosed or relapsed/refractory. The above summary is just to let you know about the positive results of early phase clinical studies with this specific drug combination.
Happy Holidays.
In newly diagnosed patients, one can recommend a handful of 2 and 3 drug combinations as standard of care. Each with differing toxicities and response rates. However, we still do not know what the best choice is for our patients.
With new drugs like carfilzomib, which had excellent activity alone and even better in combination with Revlimid and dexamethasone in relapsed refractory patients, we also want to know if this may improve on responses, tolerability, and eventually progression-free survival and overall survival in newly diagnosed patients. To answer this question, we need clinical trials.
The results of a phase I/II study using this combination (CRd) in 58 patients (only 51 we were evaluable) with newly diagnosed myeloma was presented at the ASH meeting this December (Jakubowiak et al ASH 2011 #631). It demonstrated very exciting results in terms of response. Responses were rapid with 46/49 patients achieving at least PR (partial response: >50% reduction) after a single cycle. These response results improved with the duration of treatment, reaching 100% ≥PR after 4 cycles and 100% ≥VGPR (very good partial response: >90% reduction), 79% CR/nCR (complete response or near CR) after 12 cycles. PFS and OS will take some time to mature (i.e., the trial has not gone on long enough to know the answers).
Remember that response dose not directly equate to progression-free survival and overall survival, but this early in the maturation of the results I would remain optimistic. Remember there always toxicities that one has to help define as well in clinical trials.
As stated above, I do recommend clinical trials for anyone with myeloma, whether newly diagnosed or relapsed/refractory. The above summary is just to let you know about the positive results of early phase clinical studies with this specific drug combination.
Happy Holidays.
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Dr. Ken Shain - Name: Ken Shain, M.D., Ph.D.
Beacon Medical Advisor
Re: Carfilzomib, Revlimid & dex for newly diagnosed myeloma
I'm curious, how do you find a clinical study? I relapsed last year, was on Revlimid, and dexamethasone for 9 months, achieved a complete response, and went off all treatment except Aredia. So, now I'm showing a very small M protein.
So my hematologist / oncologist is not a myeloma specialist. Will he know about clinical trials? Is that something I should investigate?
Thanks
So my hematologist / oncologist is not a myeloma specialist. Will he know about clinical trials? Is that something I should investigate?
Thanks
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Christina - Name: Christina
- When were you/they diagnosed?: June2005
- Age at diagnosis: 52
Re: Carfilzomib, Revlimid & dex for newly diagnosed myeloma
Hi Christina,
I found out about the NIH trial through an interview I saw with Dr. Landgren. I contacted his office at in Maryland and they had me come in. All treatment in the NIH trial is free, even though I have great health insurance.
To Dr. Shain, thanks for the long response. I appreciate the advice and I will take it to heart. I know I am in good hands at both the NIH and UPenn. That is my dilemma. However, the carfilzomib trial sounds like the one I will probably do, if I progress. As you said, and Dr. Landgren confirmed, participants after one cycle basically went from high plasma cell percentages to normal. He also told me that the side effects were relatively minor compared to the standard combo, with little peripheral neuropathy noted.
Thanks again and happy holidays to you!
I found out about the NIH trial through an interview I saw with Dr. Landgren. I contacted his office at in Maryland and they had me come in. All treatment in the NIH trial is free, even though I have great health insurance.
To Dr. Shain, thanks for the long response. I appreciate the advice and I will take it to heart. I know I am in good hands at both the NIH and UPenn. That is my dilemma. However, the carfilzomib trial sounds like the one I will probably do, if I progress. As you said, and Dr. Landgren confirmed, participants after one cycle basically went from high plasma cell percentages to normal. He also told me that the side effects were relatively minor compared to the standard combo, with little peripheral neuropathy noted.
Thanks again and happy holidays to you!
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terryl1 - Name: Terry
- Who do you know with myeloma?: self
- When were you/they diagnosed?: August 10, 2011
- Age at diagnosis: 49
Re: Carfilzomib, Revlimid & dex for newly diagnosed myeloma
The original source of almost all clinical trial data is:
http://www.clinicaltrials.gov
Dr. Rajkumar reviewed potential new myeloma drugs in a Beacon article he wrote earlier in 2011:
Rajkumar, SV, "Promising New Drugs For Myeloma: Will The Future Come Soon Enough?", The Myeloma Beacon, April 15, 2011
Reading through the recent ASH updates also will give a good sense of what possible new drugs are getting the most attention.
http://www.clinicaltrials.gov
Dr. Rajkumar reviewed potential new myeloma drugs in a Beacon article he wrote earlier in 2011:
Rajkumar, SV, "Promising New Drugs For Myeloma: Will The Future Come Soon Enough?", The Myeloma Beacon, April 15, 2011
Reading through the recent ASH updates also will give a good sense of what possible new drugs are getting the most attention.
Re: Carfilzomib, Revlimid & dex for newly diagnosed myeloma
Thanks for those replies, I guess my question is when do you try to do a clinical trial. I did the Revlimid and dexamethasone, which brought me back to complete remission, and I'm assuming that is what I'll go back on. So, is it when that doesn't work?
I guess I'm unsure what to check out. Plus, I live in northern California. Do I travel to where these trials are and how do you pay for them?
I guess I'm unsure what to check out. Plus, I live in northern California. Do I travel to where these trials are and how do you pay for them?
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Christina - Name: Christina
- When were you/they diagnosed?: June2005
- Age at diagnosis: 52
Re: Carfilzomib, Revlimid & dex for newly diagnosed myeloma
My M-spike has slowly begun to rise. At my last appointment with my oncologist at UPenn, we spoke about what treatment we would consider when my M-spike reaches 1.0. He mentioned a couple of clinical trials that are available there, and going back on Revlimid. He discussed the pros and cons of each of the courses of treatment.
For me, the Revlimid would be my choice to start with because it will disrupt my life the least. I am still working and the fact that I can take a pill instead of going to the cancer center twice a week for infusions is important. If for some reason the Revlimid doesn't work for me again, then I would consider one of the clinical trails.
I think that we have to look at what each treatment will mean for our quality of life. That is an extremely important issue for me. I am all for contributing to the advancement of the knowledge of treating this disease, but also am interested in living my life as normally as possible. Fortunately, so far, my disease has responded well to the treatment that I have received.
I hope everyone is enjoying this holiday season and will have the healthiest 2012 possible.
Nancy
For me, the Revlimid would be my choice to start with because it will disrupt my life the least. I am still working and the fact that I can take a pill instead of going to the cancer center twice a week for infusions is important. If for some reason the Revlimid doesn't work for me again, then I would consider one of the clinical trails.
I think that we have to look at what each treatment will mean for our quality of life. That is an extremely important issue for me. I am all for contributing to the advancement of the knowledge of treating this disease, but also am interested in living my life as normally as possible. Fortunately, so far, my disease has responded well to the treatment that I have received.
I hope everyone is enjoying this holiday season and will have the healthiest 2012 possible.
Nancy
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NStewart - Name: Nancy Stewart
- Who do you know with myeloma?: self
- When were you/they diagnosed?: 3/08
- Age at diagnosis: 60
7 posts
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