Relapsed Refractory Multiple MyelomaPhase 4NCT03934684
Study to Evaluate Safety Tolerability & Efficacy of Kyprolis (Carfilzomib) in Relapsed or Refractory Multiple Myeloma
A Phase 4 study testing Drug: Carfilzomib + Dexamethasone and Drug: Carfilzomib + Lenalidomide + Dexamethasone in people with Relapsed Refractory Multiple Myeloma, run by Amgen at 17 sites in India.
Trial summary
To characterize safety associated with the use of Kyprolis under the locally approved label. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Refractory Multiple Myeloma
- What is being tested?
- Drug: Carfilzomib + Dexamethasone and Drug: Carfilzomib + Lenalidomide + Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 17 sitesIndia
- Study dates
- 16 Sep 2019to 27 Jun 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Documented RRMM after last treatment. Refractory is defined as meeting 1 or more of the following: Nonresponsive to most recent therapy (stable disease [SD] or progressive disease [PD]) while on treatment, or Disease progression within 60 days of discontinuation from the most recent therapy.
- Eligible to receive Kyprolis per the locally approved label.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate hepatic function within 28 days prior to enrollment: bilirubin < 1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the ULN.
- Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 /L within 28 days prior to enrollment. (Screening ANC should be independent of granulocyte- and granulocyte macrophage-colony stimulating factor support for at least 1 week and of pegylated granulocyte stimulating factor for ≥ 2 weeks).
- Hemoglobin ≥ 80 g/L within 28 days prior to enrollment. Subjects should not have received red blood cell (RBC) transfusions for at least 7 days prior to obtaining the screening hemoglobin.
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- Platelet count ≥ 75 x 10^9/L (≥ 50 x 10^9/L if myeloma involvement in the bone marrow is ≥ 50%) within 28 days prior to enrollment. Subjects should not have received platelet transfusions for at least 7 days prior to obtaining the screening platelet count.
- Adequate renal function within 28 days prior to enrollment (either measured or calculated using a standard formula such as the Cockcroft and Gault): calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/min for subjects receiving KRd; calculated or measured CrCl of ≥ 15 mL/min for subjects receiving Kd.
- Left ventricular ejection fraction ≥ 40% as assessed by transthoracic echocardiogram (TTE) or multigated acquisition scan (MUGA).
- Females of childbearing potential (FCBP) must have a negative serum pregnancy test within the 10 to 14 days prior to enrollment and a negative urine pregnancy test within the 24 hours prior to day 1 of each cycle prior to dosing.
- Subject or legally acceptable representative has provided informed consent/assent prior to initiation of any study specific activities/procedures.
Who cannot join
- Waldenström macroglobulinemia.
- Plasma cell leukemia (> 2.0 x 10^9/L circulating plasma cells by standard differentials).
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Myelodysplastic síndrome.
- Primary amyloidosis (subjects with multiple myeloma with asymptomatic deposition of amyloid plaques found on biopsy would be eligible if all other criteria are met).
- History of other malignancy within the past 5 years, with the following exception[s]: Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. Adequately treated cervical carcinoma in situ without evidence of disease. Adequately treated breast ductal carcinoma in situ without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cáncer. Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
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- Known immediate or delayed hypersensitivity reaction to Captisol (a cyclodextrin derivative used to solubilize Kyprolis).
- Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs.
- Intolerance to hydration.
- Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant echocardiogram (ECHO) abnormalities, screening ECG with corrected QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction within 4 months prior to enrollment.
- Infiltrative pulmonary disease and/or known pulmonary hypertension.
- Active infection within 14 days prior to enrollment requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents. Such infections must be fully resolved prior to initiating study treatment.
- Pleural effusions requiring thoracentesis within 14 days prior to enrollment.
- Ascites requiring paracentesis within 14 days prior to enrollment.
- Uncontrolled hypertension, defined as an average systolic blood pressure > 159 mmHg or diastolic > 99 mm/Hg despite optimal treatment (measured following European Society of Hypertension/European Society of Cardiology [ESH/ESC] 2013 guidelines.
- Active hepatitis B virus (HBV) infection. Subjects with positive hepatitis B surface antigen (HBsAg) or core antibody (anti-HBc) that achieve sustained virologic response with antiviral therapy directed at hepatitis B are allowed. Subjects with known history or resolved infection (negative for HBsAg but positive for antibodies to surface antigen, and/or core antigen) must be screened with HBV DNA levels. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (hepatitis B surface antibody [anti-HBs] positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA.
- Known human immunodeficiency virus (HIV) infection, hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response following antiviral therapy are allowed).
- Ongoing graft-versus-host disease.
- Subjects with grade 3 or worse neuropathy within 14 days prior to enrollment.
- Antitumor therapy (eg, chemotherapy, immunotherapy, antibody therapy) or investigational agent within 28 days before enrollment or not recovered from any acute toxicity.
- Subjects on immunosuppressive therapy for graft versus host disease, even if it has resolved.
- Glucocorticoid therapy within 14 days before first dose that exceeds a cumulative dose of 160 mg or dexamethasone or equivalent dose of other corticosteroids.
- Focal radiation therapy within 7 days before enrollment. Radiation therapy to an extended field involving significant volume of bone marrow within 28 days prior to enrollment (ie, prior radiation must have been to less than 30% of the bone marrow).
- Autologous stem cell transplant less than 100 days prior to enrollment.
- Prior treatment with Kyprolis (carfilzomib).
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study. Other investigational procedures while participating in this study are excluded.
- Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment, during any breaks (interruptions) in the treatment, and for an additional 30 days after the last dose of Kyprolis. Females of childbearing potential should only be included in the study after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test.
- Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment, during any breaks (interruptions) in the treatment, and for an additional 30 days after the last dose of Kyprolis.
- NOTE: Female subjects of childbearing potential being treated with lenalidomide must agree to use 2 methods of contraception for at least 28 days before starting treatment, during treatment, during any breaks (interruptions) in the treatment, and for an additional 30 days after the last dose of treatment.
- Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 90 days after the last dose of Kyprolis.
- NOTE: Male subjects being treated with lenalidomide must agree to use a male condom with spermicide even if they have undergone a successful vasectomy.
- Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 90 days after the last dose of Kyprolis.
- Male subjects unwilling to abstain from donating sperm during treatment and for an additional 90 days after the last dose of Kyprolis.
- Subject likely to not be available to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Active hepatitis B virus (HBV) infection. Subjects with positive hepatitis B surface antigen (HBsAg) or core antibody (anti-HBc) that achieve sustained virologic response with antiviral therapy directed at hepatitis B are allowed. Subjects with known history or resolved infection (negative for HBsAg but positive for antibodies to surface antigen, and/or core antigen) must be screened with HBV DNA levels. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (hepatitis B surface antibody [anti-HBs] positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
India17 sites
M S Ramaiah Memorial Hospital
Bangalore, Karnataka, 560054
K L E S Dr Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, 590010
Cytecare Cancer Hospitals
Bengaluru, Karnataka, 560064
Cancer Institute WIA
Chennai, Tamil Nadu, 600020
Yashoda Hospital
Hyderabad, Andhra Pradesh, 500 082
Apollo Hospital
Hyderabad, Andhra Pradesh, 500033
Aster Medcity
Kochi, Kerala, 682027
Netaji Subhash Chandra Bose Cancer Research Institute
Kolkata, West Bengal, 700 094
Government Medical College
Kozhikode, Kerala, 673008
Valentis Cancer Hospital
Meerut, Uttar Pradesh, 250001
Tata Memorial Hospital
Mumbai, Maharashtra, 400 012
Mumbai Oncocare Center
Mumbai, Maharashtra, 400 056
Thangam Cancer Centre
Namakkal, Tamil Nadu, 637001
Navsanjeevani Hospital
Nashik, Maharashtra, 422 002
Heath Care Group Manavata Cancer Centre
Nashik, Maharashtra, 422 004
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, Puducherry, 605 006
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004
About this study
Official title: Post-marketing Phase 4 Study to Evaluate Safety, Tolerability, and Efficacy of Kyprolis® (Carfilzomib) in Indian Patients With Relapsed or Refractory Multiple Myeloma: A Prospective, Open-label, Non-comparative, Multicenter Study
To characterize safety associated with the use of Kyprolis under the locally approved label.
Read the detailed description
Kyprolis® (K; carfilzomib) was approved in India on 17 January 2017 as a prescription medication in combination with dexamethasone (Kd) or with lenalidomide (Revlimid®) plus dexamethasone (KRd) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) following 1 to 3 prior lines of therapy.
This non-comparative, interventional phase 4 study is designed to fulfil the post-marketing requirement to assess safety, tolerability, and efficacy of Kyprolis on Indian subjects with RRMM as per the locally approved label.
- Conditions
- Relapsed Refractory Multiple Myeloma
- Being tested
- Drug: Carfilzomib + Dexamethasone, Drug: Carfilzomib + Lenalidomide + Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: Carfilzomib + DexamethasoneDrug
Also called Kyprolis
Drug: Carfilzomib + Dexamethasone
- Carfilzomib will be administered as a 30-minute infusion.
- Dexamethasone will be taken by mouth or intravenously.
Drug: Carfilzomib + Lenalidomide + DexamethasoneDrug
Also called Kyprolis
Drug: Carfilzomib + Lenalidomide + Dexamethasone
- Carfilzomib will be administered as a 10 minute infusion.
- Lenalidomide will be taken orally.
- Dexamethasone will be taken by mouth or intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Carfilzomib + Dexamethasone | Experimental | Drug: Carfilzomib + Dexamethasone
* Carfilzomib 20 mg/m2 on days 1 and 2, and if tolerated, escalated to a target dose of 56 mg/m2 starting on day 8 of cycle 1 and thereafter.
* Dexamethasone 20 mg taken by mouth or intravenously on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle. An individual subject will receive study treatment for a maximum of 3 years if the subject has not yet experienced disease progression Receives: Drug: Drug: Carfilzomib + Dexamethasone |
| Carfilzomib+Lenalidomide+Dexamethasone | Experimental | Drug: Carfilzomib + Lenalidomide + Dexamethasone
* Carfilzomib is 20 mg/m2 on days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m2 starting on day 8 of cycle 1 and thereafter. From cycle 13, the day 8 and day 9 doses of Carfilzomib will be omitted.
* Lenalidomide 25 mg is taken orally on days 1 to 21.
* Dexamethasone 40 mg on days 1, 8, 15, and 22 of the 28-day cycles. An individual subject will receive study treatment for a maximum of 18 months consistent with the approved use in this combination. Receives: Drug: Drug: Carfilzomib + Lenalidomide + Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
A TEAE was any untoward medical occurrence in a clinical trial participant after the first dose of investigational product (IP) irrespective of a causal relationship with the IP. TEAEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03. Any clinically significant laboratory changes over time were recorded as TEAEs.
Measured: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months
Number of Participants Who Experienced Serious TEAEs
A serious TEAE was any untoward medical occurrence in a clinical trial participant after first dose of IP irrespective of a causal relationship with the IP(s), that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Measured: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months
Secondary outcomes (5)
Progression Free Survival (PFS) as Per International Myeloma Working Group-Uniform Response Criteria (IMWG-URC)
PFS was defined as the time from first dose of IP until the earliest date of disease progression (PD) or death due to any cause. PD was per IMWG-URC, with progression assessments at intervals as per local standard of care.
PD: increase of 25% from lowest response value in serum M-component and/or urine M-component and/or only in participants without measurable serum and urine M protein levels: the difference between involved and uninvolved free light chain (FLC) levels and/or only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow (BM) plasma cell percentage; definite development of new bone lesions or soft tissue plasmacytomas; development of hypercalcemia.
Medians were estimated using the Kaplan-Meier method. Corresponding 95% confidence intervals (CIs) were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
Measured: From enrollment until the end of trial or death date, whichever occurred earlier; median (min, max) time on trial was 8.7 (0.1, 37.2) months
Overall Response Rate (ORR) as Per IMWG-URC
ORR was defined as the percentage of participants for whom the best overall response was a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by the IMWG-URC.
CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, < 5% plasma cells in bone marrow (BM). sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level < 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to < 200 mg/24-hours.
The ORR 95% CIs were estimated using the Clopper-Pearson method.
Measured: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months
Clinical Benefit Rate (CBR) as Per IMWG-URC
CBR was defined as the percentage of participants with either the best overall response of sCR, CR, VGPR, PR, and minimal response (MR) as determined by the IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, < 5% plasma cells in BM. sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level < 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to < 200 mg/24-hours. MR: ≥ 25% but ≤ 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50% to 89%.
The CBR 95% CIs were estimated using the Clopper-Pearson method.
Measured: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months
Time to Response (TTR) as Per IMWG-URC
TTR was defined as the time from first dose date to the earliest date when confirmed sCR, CR, VGPR, or PR was first achieved.
CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, < 5% plasma cells in BM. sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level < 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to < 200 mg/24-hours.
Medians were estimated using the Kaplan-Meier method.
Measured: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months
Duration of Response (DOR) as Per IMWG-URC
DOR was defined as the time from first evidence of PR or better as per IMWG-URC to the earliest of PD or death due to any cause for participants with a best response of PR or better.
PD: increase of 25% from lowest response value in serum M-component and/or urine M-component and/or only in participants without measurable serum and urine M protein levels: the difference between involved and uninvolved FLC levels and/or only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell percentage; definite development of new bone lesions or soft tissue plasmacytomas; development of hypercalcemia.
Medians were estimated using the Kaplan-Meier method. Corresponding 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
Measured: From enrollment until the end of trial or death date, whichever occurred earlier; median (min, max) time on trial was 8.7 (0.1, 37.2) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start16 Sep 2019
- Primary completion23 Mar 2023
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934684
- Sponsor's protocol ID
- 20160372
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2019
- Last updated
- 11 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Phase 4 Study to Evaluate Safety, Tolerability, and Efficacy of Kyprolis® (Carfilzomib) in Indian Patients With Relapsed or Refractory Multiple Myeloma: A Prospective, Open-label, Non-comparative, Multicenter Study
- ClinicalTrials.gov ID
- NCT03934684
- Acronym / sponsor ID
- 20160372
- Conditions
- Relapsed Refractory Multiple Myeloma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Posted 2 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To characterize safety associated with the use of Kyprolis under the locally approved label.
Detailed description
Kyprolis® (K; carfilzomib) was approved in India on 17 January 2017 as a prescription medication in combination with dexamethasone (Kd) or with lenalidomide (Revlimid®) plus dexamethasone (KRd) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) following 1 to 3 prior lines of therapy.
This non-comparative, interventional phase 4 study is designed to fulfil the post-marketing requirement to assess safety, tolerability, and efficacy of Kyprolis on Indian subjects with RRMM as per the locally approved label.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carfilzomib + Dexamethasone | Experimental | Drug: Drug: Carfilzomib + DexamethasoneDrug: Carfilzomib + Dexamethasone * Carfilzomib 20 mg/m2 on days 1 and 2, and if tolerated, escalated to a target dose of 56 mg/m2 starting on day 8 of cycle 1 and thereafter. * Dexamethasone 20 mg taken by mouth or intravenously on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle. An individual subject will receive study treatment for a maximum of 3 years if the subject has not yet experienced disease progression |
| Carfilzomib+Lenalidomide+Dexamethasone | Experimental | Drug: Drug: Carfilzomib + Lenalidomide + DexamethasoneDrug: Carfilzomib + Lenalidomide + Dexamethasone * Carfilzomib is 20 mg/m2 on days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m2 starting on day 8 of cycle 1 and thereafter. From cycle 13, the day 8 and day 9 doses of Carfilzomib will be omitted. * Lenalidomide 25 mg is taken orally on days 1 to 21. * Dexamethasone 40 mg on days 1, 8, 15, and 22 of the 28-day cycles. An individual subject will receive study treatment for a maximum of 18 months consistent with the approved use in this combination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Documented RRMM after last treatment. Refractory is defined as meeting 1 or more of the following: Nonresponsive to most recent therapy (stable disease [SD] or progressive disease [PD]) while on treatment, or Disease progression within 60 days of discontinuation from the most recent therapy.
- Eligible to receive Kyprolis per the locally approved label.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate hepatic function within 28 days prior to enrollment: bilirubin < 1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the ULN.
- Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 /L within 28 days prior to enrollment. (Screening ANC should be independent of granulocyte- and granulocyte macrophage-colony stimulating factor support for at least 1 week and of pegylated granulocyte stimulating factor for ≥ 2 weeks).
Key exclusion criteria (36 listed)
- Waldenström macroglobulinemia.
- Plasma cell leukemia (> 2.0 x 10^9/L circulating plasma cells by standard differentials).
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Myelodysplastic síndrome.
- Primary amyloidosis (subjects with multiple myeloma with asymptomatic deposition of amyloid plaques found on biopsy would be eligible if all other criteria are met).
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 |
|---|---|---|
| Drug: Carfilzomib + DexamethasoneAlso: KyprolisDrug: Carfilzomib + Dexamethasone * Carfilzomib will be administered as a 30-minute infusion. * Dexamethasone will be taken by mouth or intravenously. | Drug | Carfilzomib + Dexamethasone |
| Drug: Carfilzomib + Lenalidomide + DexamethasoneAlso: KyprolisDrug: Carfilzomib + Lenalidomide + Dexamethasone * Carfilzomib will be administered as a 10 minute infusion. * Lenalidomide will be taken orally. * Dexamethasone will be taken by mouth or intravenously. | Drug | Carfilzomib+Lenalidomide+Dexamethasone |
Primary outcome
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Time frame: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months
A TEAE was any untoward medical occurrence in a clinical trial participant after the first dose of investigational product (IP) irrespective of a causal relationship with the IP. TEAEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03. Any clinically significant laboratory changes over time were recorded as TEAEs.
Number of Participants Who Experienced Serious TEAEs
Time frame: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months
A serious TEAE was any untoward medical occurrence in a clinical trial participant after first dose of IP irrespective of a causal relationship with the IP(s), that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
5 secondary outcomes
Progression Free Survival (PFS) as Per International Myeloma Working Group-Uniform Response Criteria (IMWG-URC)
Time frame: From enrollment until the end of trial or death date, whichever occurred earlier; median (min, max) time on trial was 8.7 (0.1, 37.2) months
Overall Response Rate (ORR) as Per IMWG-URC
Time frame: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months
Clinical Benefit Rate (CBR) as Per IMWG-URC
Time frame: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months
Time to Response (TTR) as Per IMWG-URC
Time frame: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months
Duration of Response (DOR) as Per IMWG-URC
Time frame: From enrollment until the end of trial or death date, whichever occurred earlier; median (min, max) time on trial was 8.7 (0.1, 37.2) months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Multiple Myeloma
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Relapsed or Refractory Multiple Myeloma
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. This study is not recruiting at the moment.
MD study director
Amgen
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Drug: Carfilzomib + Dexamethasone and Drug: Carfilzomib + Lenalidomide + Dexamethasone in people with Relapsed Refractory Multiple Myeloma, run by Amgen at 17 sites in India.
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 11 inclusion and 36 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: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in India. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) (time frame: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months). The study lists 2 primary outcomes in all. 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 11 May 2026.