Ixazomib Maintenance Study in Patients With AL Amyloidosis (NCT03618537)

🧪 Interventions in This Study

• Ixazomib (DRUG)
• Dexamethasone (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Male or female patients 18 years or older.
2. Biopsy-proven diagnosis of AL amyloidosis at the enrolling institution, according to the following standard criteria:
3. Histochemical diagnosis of amyloidosis, as based on tissue specimens with Congo red staining with exhibition of an apple-green birefringence
4. If clinical and laboratory parameters insufficient to establish AL amyloidosis or in cases of doubt, amyloid typing may be necessary
5. Measurable disease as defined by serum differential free light chain concentration (dFLC, difference between amyloid forming \[involved\] and non amyloid forming \[uninvolved\] free light chain \[FLC\]) ≥ 50 mg/L) (or M-protein of 0.5g/dl) prior to initial therapy.
6. At least one organ involved with AL amyloidosis including renal, cardiac, GI/Liver, peripheral/autonomic nervous system and/or soft tissue disease (Comenzo et al. Leukemia 2012).
7. At least a hematologic partial response (PR) defined by the updated AL response criteria (Pallidini et al. JCO 2012) to one line of initial therapy (may include induction followed by autologous stem cell transplant (ASCT)).
8. Patients must have \>10% bone marrow plasma cells (on aspirate or biopsy) at initial diagnosis.
9. At least 2 cycles of any induction therapy (that may include alkylators, corticosteroids, proteosome inhibitors, IMIDs - including in combination) or upfront ASCT (with or without preceding induction). Patients who receive ixazomib as part of initial therapy are eligible.
10. Patients must be within 12 months of the start of initial therapy.
11. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
12. Female patients who:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (8 Sites)

• Tufts Medical Center — Boston, Massachusetts
• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey
• Memorial Sloan Kettering Bergen — Montvale, New Jersey
• Memorial Sloan Kettering Commack — Commack, New York
• Memorial Sloan Kettering Westchester — Harrison, New York
• Memorial Sloan Kettering Cancer Center — New York, New York
• Memorial Sloan Kettering Nassau — Uniondale, New York

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in AL Amyloidosis

• Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial — Scottsdale, Arizona
• Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis — Boston, Massachusetts
• Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis — Orange, California
• A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement — Palo Alto, California
• A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES) — Duarte, California

Explore by condition: All AL Amyloidosis clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.