[Thelimeusa]

Stay in clinical trial or pursue other treatment?

by Thelimeusa on Fri Nov 13, 2015 1:34 pm

Hi,

My wife is on a trial at her local cancer center. The doctor is keeping her on the trial even though her numbers are getting worse. She is getting a PET scan next week to see what her myeloma is doing as she is showing signs of progression (possible lesions) I am assuming he will take her off the trial if the PET scan comes back bad.

Wife is considered high risk refractory / relapsed, diagnosed since 2006. She just had a second auto stem cell transplant January 30 and her latest bone marrow biopsy showed poor prognosis due to chromosome abnormalities (gains chromosomes 3, 5, 11, 15, 20 and 21; unbalanced translocation between chromosome 1 and 12 which resulted in gain of 1q; loss of chromosomes x and 22) Her maintenance treatment was Kyprolis, Pomalyst and dex, but she has been on Kyprolis / dex only because Pomalyst knocked down her numbers too much (platelets / white blood cells).

She is on a Phase 1 clinical trial not specific to multiple myeloma. The drug being tested is BBI608. She has completed 5 weeks of a 4-month trial.

Latest numbers
IgG 3042 mg/dl
Lambda free light chain 142.8 mg/l

Want to give trial time to work, but at the same time, don't want her to miss out on better treatments.

Fear is doctors believe she is out of options. She has done a tremendous amount of treatment since 2012 and doctors likely think she is at the end of the road. Her local cancer doctor tells her to live life to the fullest (drink, travel, and have sex!) Her dental specialist offered to take care of her end of life concerns and her M.D. Anderson doctor told her treatment will be very difficult from this point out and she should consider hospice.

What would you do if you were me? Keep her on trial or demand conventional treatment?

[Little Monkey]

Re: Stay in clinical trial or pursue other treatment?

by Little Monkey on Fri Nov 13, 2015 2:53 pm

Has CyBorD/P been tried yet among the various treatments?

[Thelimeusa]

Re: Stay in clinical trial or pursue other treatment?

by Thelimeusa on Fri Nov 13, 2015 3:15 pm

Yes, CyBorD for 3 months. Didn't work. The combination of Kyprolis, Pomalyst, and dex worked very well, but her platelets and white blood cells crashed. Doctor took her off Pomalyst and her platelets and white blood cells normalized, but her IgG and lambda light chains went up.

Think doctor should try Pomalyst only next.

I just wonder at what point do we have to drop trial because her myeloma numbers are beginning to effect kidneys, etc.

Benefits of trial:

White blood cell numbers normal
Platelets normal
Wife feels good - little side affects
Pills twice a day, no IV drugs, free from doctor visits

[JPC]

Re: Stay in clinical trial or pursue other treatment?

by JPC on Fri Nov 13, 2015 4:00 pm

Sorry to hear of your difficult situation, Thelime. The only thing that comes to mind is the expanded access programs for the monoclonal antibodies elotuzumab and daratumumab. I would ask your doctor about working that into the mix. Good luck to you and your wife.

[Multibilly]

Re: Stay in clinical trial or pursue other treatment?

by Multibilly on Sat Nov 14, 2015 10:49 am

As usual, JPC has some good suggestions regarding investigating monoclonal antibody (MAB) trials. I'm hoping by the time I progress that MABs will be approved and commonplace in the treatment of multiple myeloma. You don't say where you are located, but both dara and elo are being tested with relapsed/refractory patients in a pretty large number of locations.

[rumnting]

Re: Stay in clinical trial or pursue other treatment?

by rumnting on Sat Nov 14, 2015 11:47 am

My husband,too is running out of options. We just left Mayo yesterday. He just finished his second round of D-PACE. He tolerated it well, and it dropped his m-spike from 4.2 to 1.2. They are hoping he can stay off any treatment until he is able to get Daratumumab. He was too ill to get on that study, and now doesn't qualify for the trial because he responded to his last treatment (D-PACE).
Has your wife ever had D-PACE?

[Thelimeusa]

Re: Stay in clinical trial or pursue other treatment?

by Thelimeusa on Sat Nov 14, 2015 12:50 pm

We are in San Antonio Texas

My wife had 2 cycles of modified cvad in the hospital when she was trying to get her numbers down for Allo transplant. The cvads worked but really beat her up. Transplant Doctor said no to the Allo after the cvad treatment.

Are the modified cvads similar to D-Pace?

[Thelimeusa]

Re: Stay in clinical trial or pursue other treatment?

by Thelimeusa on Sat Nov 14, 2015 12:54 pm

Sounds like we should try for the Elo or dara trial before she gets too sick. Which one is more promising?

[JimNY]

Re: Stay in clinical trial or pursue other treatment?

by JimNY on Sat Nov 14, 2015 1:03 pm

Others may feel differently on this, but I think there is little doubt that daratumumab is the more active of the two options that you mentioned (daratumumab and elotuzumab).

There also is a drug very similar to daratumumab that is in clinical trials. It is called SAR650984. You may want to discuss it with your wife's doctor at the same time you discuss daratumumab. There are several trials of SAR650984 ongoing; here is a list of them:

https://clinicaltrials.gov/ct2/results?recr=Open&cond=myeloma&intr=sar650984

Be sure to check the detailed information about each trial, including the eligibility requirements and locations where the trial is offered.

Good luck!

[Multibilly]

Re: Stay in clinical trial or pursue other treatment?

by Multibilly on Sat Nov 14, 2015 2:43 pm

While I usually agree with Jim, I'm not sure that I would agree with that comment that dara is the "more active" of the MABs (although, I'm not entirely sure what this statement means). It is true that dara is interesting and unique in showing the ability to work as a monotherapy (no other drugs required). But the ORR and PFS results for the dara monotherpay trial isn't that compelling to really push dara as a monotherapy going forward, IMHO.

http://www.nejm.org/doi/full/10.1056/NEJMoa1506348?af=R&rss=currentIssue&

More PFS data around the dara trials that either additonally use Revlimid or Velcade will be presented at the upcoming ASH conference. That should really be insightful.

Elo (in combination with Revlimid) had some early and quite impressive PFS stats of 33 months and a response rate of 80-90%. It also demonstrated the ability to work on patients with adverse cytogenetics.

http://news.bms.com/press-release/rd-news/bristol-myers-squibb-and-abbvie-announce-progression-free-survival-data-phase-

In any case, this is really the kind of a situation where it makes a lot of sense to work with a top multiple myeloma specialist that is intimately familiar with the various MAB trials to get their recommendation for the best MAB trial to pursue given your wife's particular situation and treatment history.