Multiple MyelomaEarly Phase 1NCT05846880
VitD3 Supplementation in Patients With Multiple Myeloma
A Early Phase 1 study testing Lenalidomide, Maintenance Vitamin D and No maintenance Vitamin D in people with Multiple Myeloma, run by Amany Keruakous, MD, MS. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Lenalidomide, Maintenance Vitamin D and No maintenance Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to May 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥ 18 years of age at time of registration to Step 1.
- Patients must have history and physical exam within 28 days prior to registration.
- Patients must have Zubrod/ECOG Performance Status ≤ 2.
- Patients must have had a confirmed diagnosis of symptomatic MM (See Section 4.1) with measurable disease at the time of myeloma diagnosis that required systemic induction therapy prior to ASCT. Measurable disease is defined as measurable M protein in the serum (≥ 0.5g/dL) or urine (≥ 200 mg/24h) or serum free light chain assay (defined as ≥ 10 mg/dL [≥ 100 mg/L] on involved light chain) at the time of diagnosis. Patients with smoldering myeloma are not eligible until they have progressed to symptomatic myeloma.
- Patients must be willing and able to take DVT prophylaxis (aspirin, low molecular weight heparin, warfarin, or equivalent oral anticoagulation) and comply with lenalidomide REMS program requirements.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to registration. FCBP must agree to have a second pregnancy test within 24 hours prior to starting lenalidomide. Further, FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide. FCBP must also agree to ongoing pregnancy testing and must agree to not become pregnant for at least 3 months after the last dose of study treatment. A FCBP is a female who: 1) has achieved menarche (first menstrual cycle) at some point, 2) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months).Men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy, during the study treatment and for 3 months after the last dose of study treatment.
Show all 12Show fewer
- Patients must have evidence of adequate renal function, as defined by (1) creatinine clearance (CrCl) ≥ 10 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula. Values must be obtained within 28 days prior to registration. Estimated creatinine clearance = (140 - age) x wt (kg) x 0.85 (if female) 72 x creatinine (mg/dl)
- Patients must have adequate hepatic function defined by the following within 28 days prior to registration: Total bilirubin ≤ 1.5 x IULN (institutional upper limit of the norm) and AST and ALT ≤ 3.0 x IULN
- Patients must be acceptable for transplant per institutional guidelines:
- Patient's with human immunodeficiency virus (HIV) are eligible providing they are on effective antiretroviral therapy and have undetectable viral load at their most previous viral load test and within 6 months prior to registration.
- Patients must be able to take and swallow oral medication (capsules) whole.
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Who cannot join
- Any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
- Progressive disease at any time prior to registration.
- Intolerance to the starting dose of lenalidomide (10 mg).
- Prior allograft, prior organ transplant requiring immunosuppressive therapy, or have already received a previous autologous transplantation (e.g., requiring second ASCT at time of screening).
- Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
- Received any investigational agents within 14 days prior to registration.
Show all 12Show fewer
- Seropositive for Hepatitis B
- Seropositive for Hepatitis C
- Hypercalcemia (serum calcium level > 10.3 mg/dL) (institutional upper limit of the norm) at time of study entry.
- Patients refractory to lenalidomide.
- Patients that have received any investigational agents within 14 days prior to registration.
- Any known impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). h known allergies to any of the study drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
GCC Clinical Trials Office contact
United States1 site, 1 recruiting
- Recruiting
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
Kelly Jenkins, MSN, RN, 706-721-1206, kejenkins@augusta.edu
GCC Clinical Trials Office, Cancer_Center_Trials@augusta.edu
About this study
Official title: EVALUATION OF CHOLECALCIFEROL (VitD3) MAINTENANCE SUPPLEMENTATION IN PATIENTS WITH MULTIPLE MYELOMA (MM) UNDERGOING TRANSPLANTATION AND IN COMBINATION WITH LENALIDOMIDE MAINTENANCE
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.
Read the detailed description
Management of multiple myeloma (MM) has changed significantly over the past 10 years. The use of three drug induction therapy followed by autologous stem cell transplantation (ASCT) has become standard of care for transplant eligible patients with MM since randomized trials showed improved progression-free survival (PFS) and overall survival (OS) with three drugs, albeit in the non-transplant setting.
Evidence suggests Vitamin D deficiency is correlated with poorer outcomes in this population; however, it is unknown if intensified Vitamin D supplementation improves outcomes. This clinical trial aims to address this question and will postulate the impact of Vitamin D on immunoregulatory functions and the hematopoietic niche microenvironment.
- Conditions
- Multiple Myeloma
- Being tested
- Lenalidomide, Maintenance Vitamin D, No maintenance Vitamin D
- Keywords
- Myeloma, Multiple, Vitamin D, Vitamins, Lenalidomide, Revlimid, Cholecalciferol, Transplantation, Autologous, Vitamin D Deficiency
- Medical subject headings
- Multiple Myeloma, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
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 DDrug
Also called Cholecalciferol
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 DDrug
Also called Cholecalciferol
After replacement of vitamin D deficiency with weekly cholecalcefirol 50,000 units untill levels are > 30, stop replacement and continue monitoring levels
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Vitamin D | Experimental | 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. Receives: Drug: Lenalidomide; Drug: Maintenance Vitamin D |
| No Maintenance Vitamin D | Active comparator | 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. Receives: Drug: Lenalidomide; Drug: No maintenance Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the lymphocyte subset analysis for the two treatment arms at 120 days post autologous stem cell transplant [120 days]
Evaluate absolute lymphocyte count and the difference in subset analysis (absolute CD4 count, absolute CD8 count) 120 days after ASCT
Measured: 120 days
Secondary outcomes (8)
3 year progression free survival
To report the 3-year progression-free survival for both treatment arms - maintenance Vitamin D vs. No maintnenace Vitamin D supplementation
Measured: 3 years
Overall Response Rate post 120 days of ASCT
report the overall response rate for both treatment arms 120 days after ASCT for adult patients with multiple myeloma.
Measured: 120 Days
Overall Response Rate after transplantation
To report the overall response rate for both treatment arms 2 years after transplantation
Measured: Two Years
3 Year Overall Survival after transplantation
To report the 3-year overall survival for the two treatment arms after transplantation.
Measured: Three Years
Minimal Residual Disease status
To report the minimal residual disease status for the two treatment arms at randomization, and within 120 days after transplantation and 2 years after transplantation.
Measured: Randomization; 120 days after transplantation; two years after transplantation.
Vitamin D levels
To report the vitamin D levels between the two treatments arms before autologous stem cell transplant, within 120 days, and 3-years post-transplantation
Measured: Before autologous stem cell transplant; 120 days after transplantation; three years post-transplantation
Adverse Event Reporting
To describe the adverse events for the two treatment arms
Measured: Three years
Neutrophil and Platelet Engraftment and Transfusion Independence
Time to neutrophil and platelet engraftment as well as transfusion independence after transplantation
Measured: After transplantation, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Dec 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amany Keruakous, MD, MS.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amany Keruakous, MD, MS., Augusta University
- Investigators
- Amany Keruakous, MD, Principal investigator, Georgia Cancer Center at Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846880
- Sponsor's protocol ID
- GCC-22-044
- Status last verified
- Apr 2025
- First submitted
- 8 Feb 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF CHOLECALCIFEROL (VitD3) MAINTENANCE SUPPLEMENTATION IN PATIENTS WITH MULTIPLE MYELOMA (MM) UNDERGOING TRANSPLANTATION AND IN COMBINATION WITH LENALIDOMIDE MAINTENANCE
- ClinicalTrials.gov ID
- NCT05846880
- Acronym / sponsor ID
- GCC-22-044
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, Multiple, Vitamin D, Vitamins, Lenalidomide, Revlimid, Cholecalciferol, Transplantation, Autologous, Vitamin D Deficiency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Amany Keruakous, MD, MS.University, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Management of multiple myeloma (MM) has changed significantly over the past 10 years. The use of three drug induction therapy followed by autologous stem cell transplantation (ASCT) has become standard of care for transplant eligible patients with MM since randomized trials showed improved progression-free survival (PFS) and overall survival (OS) with three drugs, albeit in the non-transplant setting.
Evidence suggests Vitamin D deficiency is correlated with poorer outcomes in this population; however, it is unknown if intensified Vitamin D supplementation improves outcomes. This clinical trial aims to address this question and will postulate the impact of Vitamin D on immunoregulatory functions and the hematopoietic niche microenvironment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance Vitamin D | Experimental | Drug: Lenalidomide, Drug: Maintenance Vitamin DIn 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. |
| No Maintenance Vitamin D | Active comparator | Drug: Lenalidomide, Drug: No maintenance Vitamin DIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must be ≥ 18 years of age at time of registration to Step 1.
- Patients must have history and physical exam within 28 days prior to registration.
- Patients must have Zubrod/ECOG Performance Status ≤ 2.
- Patients must have had a confirmed diagnosis of symptomatic MM (See Section 4.1) with measurable disease at the time of myeloma diagnosis that required systemic induction therapy prior to ASCT. Measurable disease is defined as measurable M protein in the serum (≥ 0.5g/dL) or urine (≥ 200 mg/24h) or serum free light chain assay (defined as ≥ 10 mg/dL [≥ 100 mg/L] on involved light chain) at the time of diagnosis. Patients with smoldering myeloma are not eligible until they have progressed to symptomatic myeloma.
- Patients must be willing and able to take DVT prophylaxis (aspirin, low molecular weight heparin, warfarin, or equivalent oral anticoagulation) and comply with lenalidomide REMS program requirements.
Key exclusion criteria (12 listed)
- Any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
- Progressive disease at any time prior to registration.
- Intolerance to the starting dose of lenalidomide (10 mg).
- Prior allograft, prior organ transplant requiring immunosuppressive therapy, or have already received a previous autologous transplantation (e.g., requiring second ASCT at time of screening).
- Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: RevlimidFor 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 | Drug | Maintenance Vitamin D, No Maintenance Vitamin D |
| Maintenance Vitamin DAlso: CholecalciferolAfter 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 | Drug | Maintenance Vitamin D |
| No maintenance Vitamin DAlso: CholecalciferolAfter replacement of vitamin D deficiency with weekly cholecalcefirol 50,000 units untill levels are > 30, stop replacement and continue monitoring levels | Drug | No Maintenance Vitamin D |
Primary outcome
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
Evaluate absolute lymphocyte count and the difference in subset analysis (absolute CD4 count, absolute CD8 count) 120 days after ASCT
8 secondary outcomes
3 year progression free survival
Time frame: 3 years
Overall Response Rate post 120 days of ASCT
Time frame: 120 Days
Overall Response Rate after transplantation
Time frame: Two Years
3 Year Overall Survival after transplantation
Time frame: Three Years
Minimal Residual Disease status
Time frame: Randomization; 120 days after transplantation; two years after transplantation.
Vitamin D levels
Time frame: Before autologous stem cell transplant; 120 days after transplantation; three years post-transplantation
Adverse Event Reporting
Time frame: Three years
Neutrophil and Platelet Engraftment and Transfusion Independence
Time frame: After transplantation, an average of 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 1/2
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Multiple Myeloma (MM)
Active, not recruiting
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GCC Clinical Trials Office contact
Amany Keruakous, MD principal investigator
Georgia Cancer Center at Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lenalidomide, Maintenance Vitamin D and No maintenance Vitamin D in people with Multiple Myeloma, run by Amany Keruakous, MD, MS. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Jenkins, MSN, RN (706-721-1206, kejenkins@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.