VitD3 Supplementation in Patients With Multiple Myeloma

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Amany Keruakous, MD, MS.
Study ID
NCT05846880
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide — DRUG
    For first three cycles, taken orally once daily for 28 days at 10mg/day dose. After cycle 4, taken orally once daily at 15 mg/day dose
  • Maintenance Vitamin D — DRUG
    After replacement of vitamin D deficiency with weekly cholecalcefirol 50,000 units untill levels are \> 30, will start maintenance therapy with Monthly replacement with 50,000 IU
  • No maintenance Vitamin D — DRUG
    After replacement of vitamin D deficiency with weekly cholecalcefirol 50,000 units untill levels are \> 30, stop replacement and continue monitoring levels

Study Details

The goal of this clinical trial is to evaluate post-transplant immune reconstitution and lymphocyte recovery as well as the 3-year progression-free survival of patients with multiple myeloma in two treatment arms. One arm will receive Maintenance Vitamin D and the other arm will receive no maintenance Vitamin D prior to ASCT. Post ASCT arm 1 will have lenalidomide and maintenance VitD, and arm 2 will receive lenalidomide and no maintenance VitD. This clinical trial will also evaluate the overall response rate and survival for both treatment arms.

Key Dates

Start date
Dec 1, 2024
Status verified
Apr 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Maintenance Vitamin D
    In this arm, patients will receive maintenance Vitamin D3 prior to autologous transplantation (ASCT). Within 120 days after ASCT the following will be assessed: vitamin D level, Overall Response Rate (ORR) and Measurable Residual Disease (MRD). Then patients will receive lenalidomide and continuation of maintenance Vitamin D.
  • Active Comparator: No Maintenance Vitamin D
    In this arm, patients will receive no maintenance vitamin D prior to ASCT. Within 120 days after ASCT the following will be assessed: vitamin D level, ORR, and MRD. Then patients will receive the standard lenalidomide dose along with no maintenance vitamin D.

Primary Outcome Measure

To describe the lymphocyte subset analysis for the two treatment arms at 120 days post autologous stem cell transplant [120 days] [ Time Frame: 120 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912
Kelly Jenkins, MSN, RN
[email protected]
706-721-1206
GCC Clinical Trials Office
[email protected]
Amany Keruakous, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Augusta, GA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Georgia Cancer Center at Augusta University· Augusta, GA

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