Melphalan for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Heather J. Landau, MD - MSK Bone Marrow ...

Overseen byHeather Landau, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?Captisol Enabled Melphalan, is a new formulation of the standard of care melphalan chemotherapy that in packaged in an inactive substance that is believed to help the chemotherapy be more stable (meaning that it doesn't lose its effect or need to be administered quickly after being mixed). It may also have fewer side effects such as problems with important levels of body electrolytes such as potassium, phosphorous and magnesium; and cause less kidney and heart damage\] than standard formulation melphalan. The purpose of this study is to determine if the investigators can achieve a certain level of Captisol Enabled Melphalan that would be best to use in treating Multiple Myeloma and AL Amyloidosis.

Eligibility Criteria

This trial is for adults aged 18-75 with Multiple Myeloma or AL Amyloidosis who are undergoing an autologous transplant and have responded to prior chemotherapy. They must have adequate organ function, a certain number of cells available for transplant, and agree to avoid pregnancy. Excluded are those with recent heart issues, severe heart failure, other cancers within 3 years (with some exceptions), known allergies to the study drugs, or unsuitable conditions as determined by physicians.

Inclusion Criteria

I have shown improvement in my condition after initial treatment for myeloma.

My last cancer treatment showed some positive response.

I am willing to prevent pregnancy or fathering children during the trial.

+10 more

Exclusion Criteria

Pregnant or lactating females

I haven't had cancer besides blood cancer in the last 3 years.

I haven't had recent severe heart issues or uncontrolled heart conditions.

+4 more

Participant Groups

The trial is testing Captisol Enabled Melphalan—a new formulation of melphalan chemotherapy thought to be more stable and potentially less harmful to kidneys and heart—alongside Pegfilgrastim support during autologous hematopoietic progenitor cell transplant. The goal is finding the optimal level of this drug for treating Multiple Myeloma and AL Amyloidosis.

1Treatment groups

Experimental Treatment

Group I: MelphalanExperimental Treatment3 Interventions

Test Dose CE Melphalan 10mg/m2 with PK studies Day -12 to Day-3, CE Melphalan Dose of Target AUC 13 mg/L/h infused with PK studies Day -2, 3-10 x 10\^6 CD 34+ cells/kg reinfused Day 0, Pegfilgrastim 6mg injection Day +1