1. Doxycycline in AL amyloidosis
Phase II RCT.
Standard therapy + Doxycycline vs standard therapy
Confirmed centres:
Christian Medical College, Vellore (Dr. Anup J Devasia)
R & R Hospital, Delhi (Dr. Uday Yanamandra)
Christian Medical College, Ludhiana (Dr. Chepsy Philip)

2. RANDOMIZE 4 cycles CyBorD + Doxycycline 100mg BD End points Primary
Response after 4 cycles
Secondary
3 year EFS
3 year OS
Adverse events
Organ specific parameters
Eligibility
Patients with primary systemic amyloidosis
Non low risk patients
No known hypersensitivity to Doxycycline
4 cycles
CyBorD
2 years accrual, 3 years minimum follow up.
80% power to detect 40% improvement in response at 4 months
50 patients in each arm

3. Investigations at diagnosis After 4 cycles of therapy and
Investigations at diagnosis After 4 cycles of therapy and then every 3 months
CBC,
Creat, Ca, Ph, UA, LFT
SPEP, S FLC, IFE
24 hr. U protein, U BJP
B2 microglobulin
2DEcho with GLS
Trop T, NT Pro BNP
BM – asp/trephine/FISH
CBC,
Creat, Ca, Ph, UA, LFT
SPEP, S FLC, IFE
24 hr. U protein, U BJP
2DEcho with GLS
Trop T, NT Pro BNP

4. After 4-6 cycles of therapy
Eligible patients will be taken up for autologous SCT.
Post ASCT if CR -> Follow up every 3 months
If VGPR/PR -> Bortezomib maintenance ± Doxycycline based on the group x 2 years
If <PR/PD -> Off the study -> Other regimens.
If not eligible/unwilling for transplant.
Bortezomib maintenance ± Doxycycline based on the group to which randomized x 2 years.
If clinical progression -> off study -> Other regimens.